<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815409</url>
  </required_header>
  <id_info>
    <org_study_id>Treadmill2007</org_study_id>
    <nct_id>NCT03815409</nct_id>
  </id_info>
  <brief_title>Treadmill in the Rehabilitation of Parkinsonian Gait</brief_title>
  <official_title>Rehabilitation of Parkinsonian Gait in Body Weight Support Combined With Treadmill: a Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS National Neurological Institute &quot;C. Mondino&quot; Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS National Neurological Institute &quot;C. Mondino&quot; Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gait disorders represent disabling symptoms in Parkinson's Disease (PD). The effectiveness of&#xD;
      rehabilitation treatment with Body Weight Support Treadmill Training (BWSTT) has been&#xD;
      demonstrated in patients with stroke and spinal cord injuries, but limited data is available&#xD;
      in PD. The aim of the study is to investigate the efficacy of BWSTT in the rehabilitation of&#xD;
      gait in PD patients. Thirty-six PD inpatients were enrolled and performed rehabilitation&#xD;
      treatment for 4 weeks, with daily sessions. Subjects were randomly divided into two groups:&#xD;
      both groups underwent daily 40-minute sessions of traditional physiokinesitherapy followed by&#xD;
      20-minute sessions of overground gait training (Control group) or BWSTT (BWSTT group). The&#xD;
      efficacy of BWSTT was evaluated with clinical scales and Computerized Gait Analysis (CGA).&#xD;
      Patients were tested at baseline (T0) and at the end of the 4-week rehabilitation period&#xD;
      (T1).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gait disorders in Parkinson Disease (PD) are due to dopaminergic nigrostriatal pathways&#xD;
      degeneration and represent important components of the disability.&#xD;
&#xD;
      In PD, gait is characterized by a significant reduction of stride length. Inadequate flexion&#xD;
      at the ankle and knee, reduction of heel strike, forward-flexed trunk, reduced arm swing with&#xD;
      asymmetric stride times for lower limbs and significant stride-to-stride variability are&#xD;
      frequently associated.&#xD;
&#xD;
      The efficacy of pharmacological treatment with Levodopa is frequently incomplete and adjuvant&#xD;
      rehabilitation treatment is recommended. Body weight-supported treadmill training (BWSTT)&#xD;
      represents a promising rehabilitative approach for gait impairment in PD. Effectiveness of&#xD;
      BWSTT on gait, balance and motor function has been demonstrated in different neurological&#xD;
      diseases, especially in stroke and spinal cord injury. In PD patients, BWSTT has been tested&#xD;
      in small controlled studies that have suggested a clinically detectable beneficial effect.&#xD;
      BWSTT seems also effective in improving balance in PD. In PD, many data in literature show&#xD;
      how treadmill training, acting as a sensory cue, improves kinetic and kinematic parameters,&#xD;
      studied with computerized gait analysis (CGA) more than physiotherapy alone.&#xD;
&#xD;
      The first report of BWSTT efficacy in gait rehabilitation of PD belongs to Miyai. Ten&#xD;
      patients with PD were enrolled in a cross-over study and treated for 4 consecutive weeks with&#xD;
      BWSTT (20% of unweighting for 12 minutes followed by another 12-min period of 10% of&#xD;
      unweighting) or conventional physical therapy (CPT). The Authors showed that BWSTT was&#xD;
      superior to CPT in improving gait disturbances and disability at the end of the&#xD;
      rehabilitative period. More specifically BWSTT proved superior to CPT in improving UPDRS&#xD;
      scores, gait speed and stride length. The same study group in 2002 evaluated the 6-month&#xD;
      retention of BWSTT in PD. Twenty-four patients with PD were randomized to receive BWSTT (20%&#xD;
      of unweighting for 10 minutes + 10% of unweighting for 10 minutes + 0% of unweighting for an&#xD;
      additional 10-min period) or CPT 3 times/week for 4 consecutive weeks. All patients were&#xD;
      clinically evaluated at baseline and them monthly for 6 months. In this series, gait speed&#xD;
      significantly improved in BWSTT respect to CPT only at month 1, while the improvement in the&#xD;
      stride length was more marked in BWSTT group with respect to CPT and persisted until month 4.&#xD;
&#xD;
      In 2008 Fisher speculated on the possible central mechanism responsible for clinical effects&#xD;
      f BWSTT. Thirty subjects affected by PD were randomly assigned to three groups:&#xD;
      high-intensity group (24 sessions of BWSTT), low-intensity group (24 sessions of CPT),&#xD;
      zero-intensity group (8 weeks of education classes). Again, the high-intensity group improved&#xD;
      the most at the end of treatment period, in particular in gait speed, step length, stride&#xD;
      length and double support. Of note, that in this study a subgroup of patients was also tested&#xD;
      with transcranial magnetic stimulation: in the BWSTT group Authors were able to record a&#xD;
      lengthening of the cortical silent period, postulating that high-intensity training improved&#xD;
      neuronal plasticity in PD, through BDNF and GABA modulation.&#xD;
&#xD;
      Ustinova published the first positive case report on the short-term gait rehabilitation&#xD;
      efficacy of BWSTT delivered to a PD patient with a robotic device (Lokomat - Hocoma Inc.,&#xD;
      Volketswil, Switzerland). The intervention consisted in a 2-week gait training, delivered 3&#xD;
      times per week, with each session lasting 90 to 120 minutes.&#xD;
&#xD;
      Lo conducted a pilot study to assess the efficacy of BWSTT delivered with the Lokomat unit in&#xD;
      reducing frequency of freezing (FOG) of gait in PD. Authors reported a 20% reduction in the&#xD;
      average number of daily episodes of FOG and a 14% improvement in the FOG-questionnaire score.&#xD;
&#xD;
      In 2012 Picelli enrolled 41 PD patients in the first randomised controlled study aimed to&#xD;
      compare the efficacy of BWSTT delivered with a robot-assisted gait training (RAGT - gait&#xD;
      Trainer GT1) to CPT (not focused on gait training) in improving gait in PD. They showed how&#xD;
      RAGT was significantly superior respect to CPT in improving the 6-minute walking test, the&#xD;
      10-meter walking test, stride length, single/double support ratio, Parkinson's Fatigue Scale&#xD;
      and UPDRS score.&#xD;
&#xD;
      In the present study subjects were enrolled among consecutive PD patients hospitalized in the&#xD;
      Neuro-Rehabilitation Unit of the IRCCS Mondino Foundation of Pavia, Italy. Thirty-six&#xD;
      patients affected by Idiopathic PD, according to the UK Brain Bank diagnostic criteria were&#xD;
      included. Subjects were randomly assigned to two groups: 18 PD patients were assigned to the&#xD;
      &quot;BWSTT group&quot; and 18 patients to the &quot;Control group&quot;. Before starting treatment, patients of&#xD;
      BWSTT group performed a 20-minute single session of BWSTT in order to test feasibility and&#xD;
      tolerability. Four of them did not tolerate BWSTT: one patient reported an increase in his&#xD;
      pre-existing hip pain, two patients with pre-existing spondyloarthrosis complained of low&#xD;
      back pain, one patient reported that the procedure induced anxious symptoms. These 4 patients&#xD;
      were re-allocated to the control group, so that the final disposition of patients in the two&#xD;
      groups was as follows: 14 patients (8 women and 6 men) in the BWSTT group and 22 patients (10&#xD;
      women and 12 men) in the Control group.&#xD;
&#xD;
      Patients in both groups underwent 5 daily rehabilitation sessions per week for 4 consecutive&#xD;
      weeks. Both groups underwent daily 40-minute sessions of traditional physical therapy (PT)&#xD;
      followed by a 20-minute session of overground gait training (Control group) or of gait&#xD;
      training with BWSTT (BWSTT group).&#xD;
&#xD;
      The traditional PT rehabilitation treatment included passive, active and active-assisted&#xD;
      exercises, according to the methods commonly used (Kabat, Bobath) and previously published&#xD;
      (25, 26) Every 40-minute treatment session consisted in isotonic and isometric exercises for&#xD;
      the major muscles of the limbs and trunk including cardiovascular warm-up exercises (5&#xD;
      minutes), muscle stretching exercises (10 minutes), muscle stretching exercises for&#xD;
      functional purposes (10 minutes), balance training exercises (10 minutes), relaxation&#xD;
      exercises (5 minutes). This protocol was designed in accordance with PD rehabilitation&#xD;
      guidelines and evidences in the literature.&#xD;
&#xD;
      The sessions were conducted on a treadmill with partial weight unload. Specifically, the&#xD;
      patient performed 10-minute treadmill walk with a support corresponding to 20% of his/her own&#xD;
      weight, followed by a 5-minute rest and a second 10-minute session on the treadmill with a&#xD;
      support corresponding to 10% of his/her own weight. In the initial treadmill session, the&#xD;
      starting speed of the treadmill was set to 0.5 km/h, subsequent increments of 0.5 km/h per&#xD;
      minute were added to reach the maximum speed that was comfortably tolerated by the patient.&#xD;
      This latter was used for the entire training period.&#xD;
&#xD;
      All patients were examined by a neurologist with expertise in Movement Disorders at the&#xD;
      beginning of hospitalization (T0) and at the end of the neurorehabilitation period (+4 weeks,&#xD;
      T1). The clinical assessment involved a complete neurological examination and administration&#xD;
      of the following clinical scales, validated for the assessment of the damage/disability:&#xD;
&#xD;
        -  for the assessment of PD severity: the Unified Parkinson's Disease Rating Scale, part&#xD;
           III (UPDRS-III);&#xD;
&#xD;
        -  for the assessment of functional independence: the Functional Independence Measure&#xD;
           (FIM).&#xD;
&#xD;
      The instrumental assessment of gait was conducted at T0 and T1 by an experienced laboratory&#xD;
      Technician using an Optokinetic Gait Analysis System associated to the software Myolab Clinic&#xD;
      (ELITE, BTS Engineering Milan), composed of six infrared cameras, with a sampling rate of 100&#xD;
      Hz. According to the Davis protocol, twenty-one spherical reflective markers (15mm in&#xD;
      diameter) were applied along the body. Synchronized data acquisition and data processing were&#xD;
      performed by analyzer software (BTS, Milan, Italy). In order to perform kinematic analysis of&#xD;
      gait, patients were instructed to walk at their preferred speed along a 10-meter walkway with&#xD;
      the initial step on the side of disease onset. For each session, the investigators acquired&#xD;
      at least three performances and calculated the mean. In order to obtain the best individual&#xD;
      performance, all recordings were conducted in the ON phase. The sessions were recorded at&#xD;
      5-min intervals to allow complete recovery from fatigue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2007</start_date>
  <completion_date type="Actual">November 30, 2008</completion_date>
  <primary_completion_date type="Actual">November 30, 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>speed of gait</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>m/s - higher values represent better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale III (UPDRS-III)</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>Motor disability of Parkinson's Disease (scale from 0 to 56). Higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM)</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>Independence in activity of daily living (scale from 18 to 126). Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cadence of step</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>step/min - higher values represent better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stride duration</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>ms - higher values represent worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stride length</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>meter - higher values represent better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stance</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>percentage variation - higher values represent worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>swing</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>percentage variation - higher values represent better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of strides in 10 meters</measure>
    <time_frame>after 4-week rehabilitative program</time_frame>
    <description>number - higher values represent worse outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>BWSTT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The sessions were conducted on a treadmill with partial weight unload.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The traditional PT rehabilitation treatment included passive, active and active-assisted exercises, according to the methods commonly used (Kabat, Bobath).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill with partial weight unload</intervention_name>
    <description>10-minute treadmill walk with a support corresponding to 20% of his/her own weight, followed by a 5-minute rest and a second 10-minute session on the treadmill with a support corresponding to 10% of his/her own weight. In the initial treadmill session, the starting speed of the treadmill was set to 0.5 km/h, subsequent increments of 0.5 km/h per minute were added to reach the maximum speed that was comfortably tolerated by the patient. This latter was used for the entire training period.</description>
    <arm_group_label>BWSTT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional PT rehabilitation treatment</intervention_name>
    <description>Every 40-minute treatment session consisted in isotonic and isometric exercises for the major muscles of the limbs and trunk including cardiovascular warm-up exercises (5 minutes), muscle stretching exercises (10 minutes), muscle stretching exercises for functional purposes (10 minutes), balance training exercises (10 minutes), relaxation exercises (5 minutes)</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  disease stage 2-3 Hoehn &amp;Yahr in the &quot;on&quot; phase;&#xD;
&#xD;
          -  stable dosage of dopaminomimetic drugs for 3 months before study enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moderate to severe cognitive impairment (MMSE ≤ 21),&#xD;
&#xD;
          -  advanced PD (Hoehn and Yahr [H&amp;Y] stage &gt;3),&#xD;
&#xD;
          -  unpredictable motor fluctuations&#xD;
&#xD;
          -  moderate to severe orthopedic problems or other pathological conditions (e.g. severe&#xD;
             postural abnormalities) that might affect gait training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristina Tassorelli, Prof</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS Mondino Foundation, Pavia</affiliation>
  </overall_official>
  <reference>
    <citation>Morris ME. Movement disorders in people with Parkinson disease: a model for physical therapy. Phys Ther. 2000 Jun;80(6):578-97.</citation>
    <PMID>10842411</PMID>
  </reference>
  <reference>
    <citation>Knutsson E, Lindblom U, Martensson A. Lioresal and spasticity. Acta Neurol Scand Suppl. 1972;51:449-50. No abstract available.</citation>
    <PMID>4514375</PMID>
  </reference>
  <reference>
    <citation>Miyai I, Fujimoto Y, Ueda Y, Yamamoto H, Nozaki S, Saito T, Kang J. Treadmill training with body weight support: its effect on Parkinson's disease. Arch Phys Med Rehabil. 2000 Jul;81(7):849-52. doi: 10.1053/apmr.2000.4439.</citation>
    <PMID>10895994</PMID>
  </reference>
  <reference>
    <citation>Ganesan M, Pal PK, Gupta A, Sathyaprabha TN. Treadmill gait training improves baroreflex sensitivity in Parkinson's disease. Clin Auton Res. 2014 Jun;24(3):111-8. doi: 10.1007/s10286-014-0236-z.</citation>
    <PMID>24659140</PMID>
  </reference>
  <reference>
    <citation>McIntosh GC, Brown SH, Rice RR, Thaut MH. Rhythmic auditory-motor facilitation of gait patterns in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Jan;62(1):22-6. doi: 10.1136/jnnp.62.1.22.</citation>
    <PMID>9010395</PMID>
  </reference>
  <results_reference>
    <citation>Bowes SG, Clark PK, Leeman AL, O'Neill CJ, Weller C, Nicholson PW, Deshmukh AA, Dobbs SM, Dobbs RJ. Determinants of gait in the elderly parkinsonian on maintenance levodopa/carbidopa therapy. Br J Clin Pharmacol. 1990 Jul;30(1):13-24. doi: 10.1111/j.1365-2125.1990.tb03738.x.</citation>
    <PMID>2202385</PMID>
  </results_reference>
  <results_reference>
    <citation>Miyai I, Fujimoto Y, Yamamoto H, Ueda Y, Saito T, Nozaki S, Kang J. Long-term effect of body weight-supported treadmill training in Parkinson's disease: a randomized controlled trial. Arch Phys Med Rehabil. 2002 Oct;83(10):1370-3. doi: 10.1053/apmr.2002.34603.</citation>
    <PMID>12370870</PMID>
  </results_reference>
  <results_reference>
    <citation>Toole T, Maitland CG, Warren E, Hubmann MF, Panton L. The effects of loading and unloading treadmill walking on balance, gait, fall risk, and daily function in Parkinsonism. NeuroRehabilitation. 2005;20(4):307-22.</citation>
    <PMID>16403997</PMID>
  </results_reference>
  <results_reference>
    <citation>Mehrholz J, Kugler J, Storch A, Pohl M, Hirsch K, Elsner B. Treadmill training for patients with Parkinson's disease. Cochrane Database Syst Rev. 2015 Sep 13;2015(9):CD007830. doi: 10.1002/14651858.CD007830.pub4.</citation>
    <PMID>26363646</PMID>
  </results_reference>
  <results_reference>
    <citation>Ganesan M, Sathyaprabha TN, Pal PK, Gupta A. Partial Body Weight-Supported Treadmill Training in Patients With Parkinson Disease: Impact on Gait and Clinical Manifestation. Arch Phys Med Rehabil. 2015 Sep;96(9):1557-65. doi: 10.1016/j.apmr.2015.05.007. Epub 2015 May 23.</citation>
    <PMID>26008873</PMID>
  </results_reference>
  <results_reference>
    <citation>Bartolo M, Serrao M, Tassorelli C, Don R, Ranavolo A, Draicchio F, Pacchetti C, Buscone S, Perrotta A, Furnari A, Bramanti P, Padua L, Pierelli F, Sandrini G. Four-week trunk-specific rehabilitation treatment improves lateral trunk flexion in Parkinson's disease. Mov Disord. 2010 Feb 15;25(3):325-31. doi: 10.1002/mds.23007.</citation>
    <PMID>20131386</PMID>
  </results_reference>
  <results_reference>
    <citation>Tassorelli C, De Icco R, Alfonsi E, Bartolo M, Serrao M, Avenali M, De Paoli I, Conte C, Pozzi NG, Bramanti P, Nappi G, Sandrini G. Botulinum toxin type A potentiates the effect of neuromotor rehabilitation of Pisa syndrome in Parkinson disease: a placebo controlled study. Parkinsonism Relat Disord. 2014 Nov;20(11):1140-4. doi: 10.1016/j.parkreldis.2014.07.015. Epub 2014 Aug 13.</citation>
    <PMID>25175601</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815409
org study id: Treadmill2007
nct id: NCT03815409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gait disorders represent disabling symptoms in Parkinson's Disease (PD). The effectiveness of
      rehabilitation treatment with Body Weight Support Treadmill Training (BWSTT) has been
      demonstrated in patients with stroke and spinal cord injuries, but limited data is available
      in PD. The aim of the study is to investigate the efficacy of BWSTT in the rehabilitation of
      gait in PD patients. Thirty-six PD inpatients were enrolled and performed rehabilitation
      treatment for 4 weeks, with daily sessions. Subjects were randomly divided into two groups:
      both groups underwent daily 40-minute sessions of traditional physiokinesitherapy followed by
      20-minute sessions of overground gait training (Control group) or BWSTT (BWSTT group). The
      efficacy of BWSTT was evaluated with clinical scales and Computerized Gait Analysis (CGA).
      Patients were tested at baseline (T0) and at the end of the 4-week rehabilitation period
      (T1).
Gait disorders in Parkinson Disease (PD) are due to dopaminergic nigrostriatal pathways
      degeneration and represent important components of the disability.

      In PD, gait is characterized by a significant reduction of stride length. Inadequate flexion
      at the ankle and knee, reduction of heel strike, forward-flexed trunk, reduced arm swing with
      asymmetric stride times for lower limbs and significant stride-to-stride variability are
      frequently associated.

      The efficacy of pharmacological treatment with Levodopa is frequently incomplete and adjuvant
      rehabilitation treatment is recommended. Body weight-supported treadmill training (BWSTT)
      represents a promising rehabilitative approach for gait impairment in PD. Effectiveness of
      BWSTT on gait, balance and motor function has been demonstrated in different neurological
      diseases, especially in stroke and spinal cord injury. In PD patients, BWSTT has been tested
      in small controlled studies that have suggested a clinically detectable beneficial effect.
      BWSTT seems also effective in improving balance in PD. In PD, many data in literature show
      how treadmill training, acting as a sensory cue, improves kinetic and kinematic parameters,
      studied with computerized gait analysis (CGA) more than physiotherapy alone.

      The first report of BWSTT efficacy in gait rehabilitation of PD belongs to Miyai. Ten
      patients with PD were enrolled in a cross-over study and treated for 4 consecutive weeks with
      BWSTT (20% of unweighting for 12 minutes followed by another 12-min period of 10% of
      unweighting) or conventional physical therapy (CPT). The Authors showed that BWSTT was
      superior to CPT in improving gait disturbances and disability at the end of the
      rehabilitative period. More specifically BWSTT proved superior to CPT in improving UPDRS
      scores, gait speed and stride length. The same study group in 2002 evaluated the 6-month
      retention of BWSTT in PD. Twenty-four patients with PD were randomized to receive BWSTT (20%
      of unweighting for 10 minutes + 10% of unweighting for 10 minutes + 0% of unweighting for an
      additional 10-min period) or CPT 3 times/week for 4 consecutive weeks. All patients were
      clinically evaluated at baseline and them monthly for 6 months. In this series, gait speed
      significantly improved in BWSTT respect to CPT only at month 1, while the improvement in the
      stride length was more marked in BWSTT group with respect to CPT and persisted until month 4.

      In 2008 Fisher speculated on the possible central mechanism responsible for clinical effects
      f BWSTT. Thirty subjects affected by PD were randomly assigned to three groups:
      high-intensity group (24 sessions of BWSTT), low-intensity group (24 sessions of CPT),
      zero-intensity group (8 weeks of education classes). Again, the high-intensity group improved
      the most at the end of treatment period, in particular in gait speed, step length, stride
      length and double support. Of note, that in this study a subgroup of patients was also tested
      with transcranial magnetic stimulation: in the BWSTT group Authors were able to record a
      lengthening of the cortical silent period, postulating that high-intensity training improved
      neuronal plasticity in PD, through BDNF and GABA modulation.

      Ustinova published the first positive case report on the short-term gait rehabilitation
      efficacy of BWSTT delivered to a PD patient with a robotic device (Lokomat - Hocoma Inc.,
      Volketswil, Switzerland). The intervention consisted in a 2-week gait training, delivered 3
      times per week, with each session lasting 90 to 120 minutes.

      Lo conducted a pilot study to assess the efficacy of BWSTT delivered with the Lokomat unit in
      reducing frequency of freezing (FOG) of gait in PD. Authors reported a 20% reduction in the
      average number of daily episodes of FOG and a 14% improvement in the FOG-questionnaire score.

      In 2012 Picelli enrolled 41 PD patients in the first randomised controlled study aimed to
      compare the efficacy of BWSTT delivered with a robot-assisted gait training (RAGT - gait
      Trainer GT1) to CPT (not focused on gait training) in improving gait in PD. They showed how
      RAGT was significantly superior respect to CPT in improving the 6-minute walking test, the
      10-meter walking test, stride length, single/double support ratio, Parkinson's Fatigue Scale
      and UPDRS score.

      In the present study subjects were enrolled among consecutive PD patients hospitalized in the
      Neuro-Rehabilitation Unit of the IRCCS Mondino Foundation of Pavia, Italy. Thirty-six
      patients affected by Idiopathic PD, according to the UK Brain Bank diagnostic criteria were
      included. Subjects were randomly assigned to two groups: 18 PD patients were assigned to the
      "BWSTT group" and 18 patients to the "Control group". Before starting treatment, patients of
      BWSTT group performed a 20-minute single session of BWSTT in order to test feasibility and
      tolerability. Four of them did not tolerate BWSTT: one patient reported an increase in his
      pre-existing hip pain, two patients with pre-existing spondyloarthrosis complained of low
      back pain, one patient reported that the procedure induced anxious symptoms. These 4 patients
      were re-allocated to the control group, so that the final disposition of patients in the two
      groups was as follows: 14 patients (8 women and 6 men) in the BWSTT group and 22 patients (10
      women and 12 men) in the Control group.

      Patients in both groups underwent 5 daily rehabilitation sessions per week for 4 consecutive
      weeks. Both groups underwent daily 40-minute sessions of traditional physical therapy (PT)
      followed by a 20-minute session of overground gait training (Control group) or of gait
      training with BWSTT (BWSTT group).

      The traditional PT rehabilitation treatment included passive, active and active-assisted
      exercises, according to the methods commonly used (Kabat, Bobath) and previously published
      (25, 26) Every 40-minute treatment session consisted in isotonic and isometric exercises for
      the major muscles of the limbs and trunk including cardiovascular warm-up exercises (5
      minutes), muscle stretching exercises (10 minutes), muscle stretching exercises for
      functional purposes (10 minutes), balance training exercises (10 minutes), relaxation
      exercises (5 minutes). This protocol was designed in accordance with PD rehabilitation
      guidelines and evidences in the literature.

      The sessions were conducted on a treadmill with partial weight unload. Specifically, the
      patient performed 10-minute treadmill walk with a support corresponding to 20% of his/her own
      weight, followed by a 5-minute rest and a second 10-minute session on the treadmill with a
      support corresponding to 10% of his/her own weight. In the initial treadmill session, the
      starting speed of the treadmill was set to 0.5 km/h, subsequent increments of 0.5 km/h per
      minute were added to reach the maximum speed that was comfortably tolerated by the patient.
      This latter was used for the entire training period.

      All patients were examined by a neurologist with expertise in Movement Disorders at the
      beginning of hospitalization (T0) and at the end of the neurorehabilitation period (+4 weeks,
      T1). The clinical assessment involved a complete neurological examination and administration
      of the following clinical scales, validated for the assessment of the damage/disability:

        -  for the assessment of PD severity: the Unified Parkinson's Disease Rating Scale, part
           III (UPDRS-III);

        -  for the assessment of functional independence: the Functional Independence Measure
           (FIM).

      The instrumental assessment of gait was conducted at T0 and T1 by an experienced laboratory
      Technician using an Optokinetic Gait Analysis System associated to the software Myolab Clinic
      (ELITE, BTS Engineering Milan), composed of six infrared cameras, with a sampling rate of 100
      Hz. According to the Davis protocol, twenty-one spherical reflective markers (15mm in
      diameter) were applied along the body. Synchronized data acquisition and data processing were
      performed by analyzer software (BTS, Milan, Italy). In order to perform kinematic analysis of
      gait, patients were instructed to walk at their preferred speed along a 10-meter walkway with
      the initial step on the side of disease onset. For each session, the investigators acquired
      at least three performances and calculated the mean. In order to obtain the best individual
      performance, all recordings were conducted in the ON phase. The sessions were recorded at
      5-min intervals to allow complete recovery from fatigue.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: speed of gait
time frame: after 4-week rehabilitative program
description: m/s - higher values represent better outcome
measure: Unified Parkinson's Disease Rating Scale III (UPDRS-III)
time frame: after 4-week rehabilitative program
description: Motor disability of Parkinson's Disease (scale from 0 to 56). Higher values represent a worse outcome.
measure: Functional Independence Measure (FIM)
time frame: after 4-week rehabilitative program
description: Independence in activity of daily living (scale from 18 to 126). Higher values represent a better outcome.
measure: Cadence of step
time frame: after 4-week rehabilitative program
description: step/min - higher values represent better outcome
measure: stride duration
time frame: after 4-week rehabilitative program
description: ms - higher values represent worse outcome
measure: stride length
time frame: after 4-week rehabilitative program
description: meter - higher values represent better outcome
measure: stance
time frame: after 4-week rehabilitative program
description: percentage variation - higher values represent worse outcome
measure: swing
time frame: after 4-week rehabilitative program
description: percentage variation - higher values represent better outcome
measure: number of strides in 10 meters
time frame: after 4-week rehabilitative program
description: number - higher values represent worse outcome
arm group label: BWSTT group
arm group type: Experimental
description: The sessions were conducted on a treadmill with partial weight unload.
arm group label: Control group
arm group type: Other
description: The traditional PT rehabilitation treatment included passive, active and active-assisted exercises, according to the methods commonly used (Kabat, Bobath).
intervention type: Other
intervention name: Treadmill with partial weight unload
description: 10-minute treadmill walk with a support corresponding to 20% of his/her own weight, followed by a 5-minute rest and a second 10-minute session on the treadmill with a support corresponding to 10% of his/her own weight. In the initial treadmill session, the starting speed of the treadmill was set to 0.5 km/h, subsequent increments of 0.5 km/h per minute were added to reach the maximum speed that was comfortably tolerated by the patient. This latter was used for the entire training period.
arm group label: BWSTT group
intervention type: Other
intervention name: Traditional PT rehabilitation treatment
description: Every 40-minute treatment session consisted in isotonic and isometric exercises for the major muscles of the limbs and trunk including cardiovascular warm-up exercises (5 minutes), muscle stretching exercises (10 minutes), muscle stretching exercises for functional purposes (10 minutes), balance training exercises (10 minutes), relaxation exercises (5 minutes)
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cristina Tassorelli, Prof
role: Study Director
affiliation: IRCCS Mondino Foundation, Pavia
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PMID: 9010395
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PMID: 12370870
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PMID: 16403997
citation: Mehrholz J, Kugler J, Storch A, Pohl M, Hirsch K, Elsner B. Treadmill training for patients with Parkinson's disease. Cochrane Database Syst Rev. 2015 Sep 13;2015(9):CD007830. doi: 10.1002/14651858.CD007830.pub4.
PMID: 26363646
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PMID: 26008873
citation: Bartolo M, Serrao M, Tassorelli C, Don R, Ranavolo A, Draicchio F, Pacchetti C, Buscone S, Perrotta A, Furnari A, Bramanti P, Padua L, Pierelli F, Sandrini G. Four-week trunk-specific rehabilitation treatment improves lateral trunk flexion in Parkinson's disease. Mov Disord. 2010 Feb 15;25(3):325-31. doi: 10.1002/mds.23007.
PMID: 20131386
citation: Tassorelli C, De Icco R, Alfonsi E, Bartolo M, Serrao M, Avenali M, De Paoli I, Conte C, Pozzi NG, Bramanti P, Nappi G, Sandrini G. Botulinum toxin type A potentiates the effect of neuromotor rehabilitation of Pisa syndrome in Parkinson disease: a placebo controlled study. Parkinsonism Relat Disord. 2014 Nov;20(11):1140-4. doi: 10.1016/j.parkreldis.2014.07.015. Epub 2014 Aug 13.
PMID: 25175601
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No