Effect of Rhythmic Upper-limb Training in Stroke Patients

Cerebral Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139553
• Other study ID #: ULRM-001
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: January 23, 2017
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Woluwe-St-Lambert	Brabant Wallon

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	1 week to 1 day before therapy and 1 day to 1 week after therapy
Secondary	Therapy after effects	Evolution of the movement smoothness in rhythmic and discrete movements, the movement accuracy in discrete movements and the general motricity	1 day to one week after therapy and 3 months after therapy
Secondary	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	4 to 5 weeks before therapy and 1 week to 1 day before therapy