NCT02139553

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

April 30, 2014

Last Update Submit

January 23, 2017

Conditions

Cerebral Stroke

Keywords

Rhythmic versus discrete movementsRehabilitation

Outcome Measures

Primary Outcomes (4)

  • 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

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

  • 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

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

  • 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.

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

  • 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

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

Secondary Outcomes (3)

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

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

  • Therapy after effects

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

  • Assessment of the natural evolution of the patient

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

Study Arms (1)

Rhythmic rehabilitation

EXPERIMENTAL

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

Interventions

Rhythmic rehabilitationPROCEDURE

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

Rhythmic rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

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

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 15, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Study Completion

June 1, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

BE(1)