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Effect of Rhythmic Upper-limb Training in Stroke Patients

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: NCT02139553
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
The purpose of this study is to determine whether rhythmic upper-limb movement training in post-stroke patients allows to improve only this particular type of movements or if it also improves some parameters of discrete movements. Based on our results we hope to be able to answer a fundamental question: are rhythmic and discrete movements two independent primitives?

Condition or disease Intervention/treatment Phase
Cerebral Stroke Procedure: Rhythmic rehabilitation Not Applicable

Detailed Description:
Patients are assessed four times during this longitudinal study. One month separates the first two assessment, next patients are trained 12 times during one month with rhythmic movement training on an end-effector robot. After this month, patients are assessed a third time and three months later a fourth time in order to study long-time benefits of the therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : May 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Rhythmic rehabilitation
Patients undergo a first evaluation, and a second evaluation one month later to determine their natural evolution. The following month, patients get 12 sessions of rhythmic therapy. A third evaluation is organized straight after this month and a fourth evaluation, 3 months after to assess the after-effects of the therapy.
Procedure: Rhythmic rehabilitation
Stroke patients have 12 rehabilitation sessions on a planar rehabilitation robot, Reaplan, focussed on rhythmic arm movements.




Primary Outcome Measures :
  1. Change in movement smoothness in rhythmic straight movements after one month of rhythmic therapy [ Time Frame: 1 week to 1 day before therapy and 1 day to 1 week after therapy ]

    Patients are asked to fulfill rhythmic movements on the end-effector robot Reaplan. The smoothness is assessed with following metrics:

    • number of peaks in velocity profile
    • TENT value
    • logarithmic dimensionless square jerk

  2. Change in movement smoothness in discrete straight movements after one month of rhythmic therapy [ Time Frame: 1 week to 1 day before therapy and 1 day to 1 week after therapy ]

    Patients are asked to fulfill discrete movements on the end-effector robot Reaplan. The smoothness is assessed with following metrics:

    • number of peaks in velocity profile
    • TENT value
    • logarithmic dimensionless square jerk

  3. Change in accuracy of discrete straight movements after one month of rhythmic therapy [ Time Frame: 1 week to 1 day before therapy and 1 day to 1 week after therapy ]
    Patients are asked to fulfill discrete movements on the end-effector robot Reaplan. The accuracy is assessed.

  4. Change in smoothness of rhythmic circular movement after rhythmic therapy [ Time Frame: 1 day to 1 week before therapy and 1day to 1 week after therapy ]
    Patients are asked to fulfill 10 circular movements on the end-effector robot Reaplan. The movement smoothness are assessed


Secondary Outcome Measures :
  1. Change of the general motricity of the patient due to one month rhythmic therapy [ Time Frame: 1 week to 1 day before therapy and 1 day to 1 week after therapy ]
    1. Upper limb Fugl-Meyer Assessment
    2. Box and block test
    3. Ashworth test

  2. Therapy after effects [ Time Frame: 1 day to one week after therapy and 3 months after therapy ]
    Evolution of the movement smoothness in rhythmic and discrete movements, the movement accuracy in discrete movements and the general motricity

  3. Assessment of the natural evolution of the patient [ Time Frame: 4 to 5 weeks before therapy and 1 week to 1 day before therapy ]
    Natural evolution of the movement smoothness in rhythmic and discrete movements, of the accuracy in discrete movements and of the general motricity of the patient



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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:

  • more than 6 months post-stroke patients
  • Fugl-Meyer between 7 and 55
  • Maintain the same intensity of rehabilitation during the study

Exclusion Criteria:

  • cerebellar stroke
  • severe aphasia or cognitive disorder
  • any other neurological disorder

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): NCT02139553


Locations
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Belgium
Cliniques universitaires Saint-Luc
Woluwe-St-Lambert, Brabant Wallon, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02139553    
Other Study ID Numbers: ULRM-001
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Rhythmic versus discrete movements
Rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases