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Effect of Rhythmic Upper-limb Training in Stroke Patients

Primary Purpose

Cerebral Stroke

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Rhythmic rehabilitation

About this trial

This is an interventional treatment trial for Cerebral Stroke focused on measuring Rhythmic versus discrete movements, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rhythmic rehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in movement smoothness in rhythmic straight movements after one month of rhythmic 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

Change in movement smoothness in discrete straight movements after one month of rhythmic 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

Change in accuracy of discrete straight movements after one month of rhythmic therapy

Patients are asked to fulfill discrete movements on the end-effector robot Reaplan. The accuracy is assessed.

Change in smoothness of rhythmic circular movement after rhythmic therapy

Patients are asked to fulfill 10 circular movements on the end-effector robot Reaplan. The movement smoothness are assessed

Secondary Outcome Measures

Change of the general motricity of the patient due to one month rhythmic therapy

Upper limb Fugl-Meyer Assessment Box and block test Ashworth test

Therapy after effects

Evolution of the movement smoothness in rhythmic and discrete movements, the movement accuracy in discrete movements and the general motricity

Assessment of the natural evolution of the patient

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

Full Information

NCT ID

NCT02139553

First Posted

April 30, 2014

Last Updated

January 23, 2017

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT02139553

Brief Title

Effect of Rhythmic Upper-limb Training in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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?

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Stroke

Keywords

Rhythmic versus discrete movements, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rhythmic rehabilitation

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Rhythmic rehabilitation

Intervention Description

Stroke patients have 12 rehabilitation sessions on a planar rehabilitation robot, Reaplan, focussed on rhythmic arm movements.

Primary Outcome Measure Information:

Title

Change in movement smoothness in rhythmic straight movements after one month of rhythmic therapy

Description

Time Frame

1 week to 1 day before therapy and 1 day to 1 week after therapy

Title

Change in movement smoothness in discrete straight movements after one month of rhythmic therapy

Description

Time Frame

1 week to 1 day before therapy and 1 day to 1 week after therapy

Title

Change in accuracy of discrete straight movements after one month of rhythmic therapy

Description

Patients are asked to fulfill discrete movements on the end-effector robot Reaplan. The accuracy is assessed.

Time Frame

1 week to 1 day before therapy and 1 day to 1 week after therapy

Title

Change in smoothness of rhythmic circular movement after rhythmic therapy

Description

Patients are asked to fulfill 10 circular movements on the end-effector robot Reaplan. The movement smoothness are assessed

Time Frame

1 day to 1 week before therapy and 1day to 1 week after therapy

Secondary Outcome Measure Information:

Title

Change of the general motricity of the patient due to one month rhythmic therapy

Description

Upper limb Fugl-Meyer Assessment Box and block test Ashworth test

Time Frame

1 week to 1 day before therapy and 1 day to 1 week after therapy

Title

Therapy after effects

Description

Evolution of the movement smoothness in rhythmic and discrete movements, the movement accuracy in discrete movements and the general motricity

Time Frame

1 day to one week after therapy and 3 months after therapy

Title

Assessment of the natural evolution of the patient

Description

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

Time Frame

4 to 5 weeks before therapy and 1 week to 1 day before therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Cliniques universitaires Saint-Luc

City

Woluwe-St-Lambert

State/Province

Brabant Wallon

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effect of Rhythmic Upper-limb Training in Stroke Patients

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