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Effect of I-TRAVLE Training on Arm Function in MS and Chronic Stroke Patients

NCT01918748 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-08-08

No results posted yet for this study

Summary

Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke patients have not reached their full potential when they are discharged from hospital. It is proven that extra training opportunities lead to further improvement. To date, new training possibilities, such as robotic techniques for rehabilitation, virtual reality training systems and tele-rehabilitation are being developed to aid in the training of stroke patients.

Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive 6-week technology-assisted training regime, featuring a robotics-based self-adapting arm training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and arm skill performance in chronic stroke patients with low to moderate proximal (shoulder/arm) muscle strength.

Study design: single arm prospective cohort study. Study population: 16 stroke patients in the chronic phase after their stroke, aged \>=18, diagnosed with a central paresis of the arm, having low to moderate proximal (shoulder and arm) muscle strength.

Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or challenges the patient to perform movements of the arm, thereby training motor control and co-ordination of the affected arm. Also strength and endurance of arm muscle use may be trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at least half an hour to avoid (general) fatigue and overuse.

Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the start of the intervention, each interspaced by 1 week to assess baseline stability or any fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training. Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling. Secondary outcome measures are: motricity index, plate tapping task, active range of motion, perceived strength and fatigue.

Conditions

Interventions

DEVICE

Haptic Master

The Haptic Master (HM) is a haptic device controlled according to the principles of 'admittance control'. In admittance control 'force' applied to the system (i.e. the HM arm) is measured, while 'position' (of the HM arm) is the end result.

Sponsors & Collaborators

  • Hasselt University

    lead OTHER

Principal Investigators

  • Peter Feys, Doctor · University Hasselt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-06-30
Completion
2014-09-30

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918748 on ClinicalTrials.gov