Effect of Rhythmic Upper-limb Training in Stroke Patients

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

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?

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Belgium

Cliniques universitaires Saint-Luc

Woluwe-St-Lambert, Brabant Wallon, Belgium, 1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

More Information

• 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
• 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:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases