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Treadmill in the Rehabilitation of Parkinsonian Gait

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03815409
Recruitment Status : Completed
First Posted : January 24, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Treadmill with partial weight unload Other: Traditional PT rehabilitation treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation of Parkinsonian Gait in Body Weight Support Combined With Treadmill: a Controlled Study
Actual Study Start Date : November 15, 2007
Actual Primary Completion Date : November 30, 2008
Actual Study Completion Date : November 30, 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BWSTT group
The sessions were conducted on a treadmill with partial weight unload.
Other: Treadmill with partial weight unload
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.

Control group
The traditional PT rehabilitation treatment included passive, active and active-assisted exercises, according to the methods commonly used (Kabat, Bobath).
Other: Traditional PT rehabilitation treatment
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)




Primary Outcome Measures :
  1. speed of gait [ Time Frame: after 4-week rehabilitative program ]
    m/s - higher values represent better outcome


Secondary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale III (UPDRS-III) [ Time Frame: after 4-week rehabilitative program ]
    Motor disability of Parkinson's Disease (scale from 0 to 56). Higher values represent a worse outcome.

  2. Functional Independence Measure (FIM) [ Time Frame: after 4-week rehabilitative program ]
    Independence in activity of daily living (scale from 18 to 126). Higher values represent a better outcome.

  3. Cadence of step [ Time Frame: after 4-week rehabilitative program ]
    step/min - higher values represent better outcome

  4. stride duration [ Time Frame: after 4-week rehabilitative program ]
    ms - higher values represent worse outcome

  5. stride length [ Time Frame: after 4-week rehabilitative program ]
    meter - higher values represent better outcome

  6. stance [ Time Frame: after 4-week rehabilitative program ]
    percentage variation - higher values represent worse outcome

  7. swing [ Time Frame: after 4-week rehabilitative program ]
    percentage variation - higher values represent better outcome

  8. number of strides in 10 meters [ Time Frame: after 4-week rehabilitative program ]
    number - higher values represent worse outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • disease stage 2-3 Hoehn &Yahr in the "on" phase;
  • stable dosage of dopaminomimetic drugs for 3 months before study enrollment

Exclusion Criteria:

  • moderate to severe cognitive impairment (MMSE ≤ 21),
  • advanced PD (Hoehn and Yahr [H&Y] stage >3),
  • unpredictable motor fluctuations
  • moderate to severe orthopedic problems or other pathological conditions (e.g. severe postural abnormalities) that might affect gait training.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815409


Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Investigators
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Study Director: Cristina Tassorelli, Prof IRCCS Mondino Foundation, Pavia
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT03815409    
Other Study ID Numbers: Treadmill2007
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases