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Completed

NCT Number: NCT02139553

Effect of Rhythmic Upper-limb Training in Stroke Patients

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?

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhythmic rehabilitation

Procedure

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

Primary outcomes

  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 outcomes

  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

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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
May 15, 2014
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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