Intelligent Activity-based Client-centred Training

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether additional therapy with i-ACT system is effective in the training of functional skills in persons with central neurological diseases (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).

Official Title
-----------------
Intelligent Activity-based Client-centred Training

Conditions
-----------------
Central Nervous System Diseases, Aged

Intervention / Treatment
-----------------
* Device: i-ACT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical diagnosis of central nervous system disease (e.g. multiple sclerosis, stroke, spinal cord, etc.) Be able to understand and respond to questions in Dutch Actively involved in a rehabilitation programme in the participating rehabilitation centres Have a dysfunction in upper and/or lower limb and/or core stability Specifically for multiple sclerosis: min. of one month without corticosteroids Specifically for stroke and spinal cord: min. 3 months post injury Exclusion Criteria: Severe spasticity which prevent performing basic functional exercises Severe cognitive and communicative impairment which prevent the person to understand and respond to Dutch instructions Severe visual impairment, e.g. blindness, cataract, etc. Pregnancy Persons who use an electrical wheelchair, who can not transfer safely into a normal chair and perform the exercises

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Therapy as usual, i.e. occupational therapy, physiotherapy, etc. | |
| Experimental: Experimental group<br>Therapy as usual together with 3x45min training with i-ACT system during 6 weeks. | Device: i-ACT<br>* 3x 45 min training with i-ACT system (analytical and functional training) during 6 weeks, additional to therapy as usual (i.e. occupational therapy, physiotherapy, etc.)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test (WMFT) | Evaluation of upper extremity | At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up | 
| Short Form 36 (SF-36) | Evaluation of general health status and quality of life | At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrinsic Motivation Inventory (IMI) | Evaluation of motivation towards using the system in neurorehabilitation | After 6 weeks of training, only persons in experimental group | 
| Manual Ability Measure (MAM-36) | Evaluation of performance of manual tasks | At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up | 
| Modified Fatigue Impact Scale (MFIS) | Evaluation of fatigue | At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up | 
| Trunk Impairment Scale (TIS) | Evaluation of sitting, standing and core stability | At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up | 
| Active Range of Motion (AROM) | Evaluation of active range of motion | At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up | 
| Canadian Occupational Performance Measure (COPM) | Evaluation of self-perception of performance of ADL tasks | At baseline, after 6 weeks of training, and 6 weeks follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Activity-based, Client-centred, Rehabilitation, Quality of life