Intelligent Activity-based Client-centred Training

Not Applicable

Completed

• Conditions: Central Nervous System Diseases; Aged

• Registration Number: NCT02982811
• Lead Sponsor: PXL University College

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.).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-05
• Study Start: 2017-03-01
• Primary Completion: 2020-05-31
• Study Completion: 2020-06-26
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Jessa Hospital - rehabilitation campus St-Ursula; 🇧🇪 Herk-de-Stad, Limburg, Belgium

Ziekenhuis Oost Limburg; 🇧🇪 Lanaken, Limburg, Belgium

Revalidatie en MS centrum; 🇧🇪 Overpelt, Limburg, Belgium

St-Trudo hospital; 🇧🇪 Sint-Truiden, Limburg, Belgium