Intelligent Activity-based Client-centred Training

Aged Clinical Trial

— i-ACT  

Official title:

Intelligent Activity-based Client-centred Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982811
• Other study ID #: i-ACT2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 26, 2020

Study information

• Verified date: July 2020
• Source: PXL University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 26, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Central Nervous System Diseases
• Nervous System Diseases

Intervention

Device:
• i-ACT
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.)

Locations

Country	Name	City	State
Belgium	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

Sponsors (4)

Lead Sponsor	Collaborator
PXL University College	Hasselt University, Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wolf Motor Function Test (WMFT)	Evaluation of upper extremity	At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Primary	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	Intrinsic Motivation Inventory (IMI)	Evaluation of motivation towards using the system in neurorehabilitation	After 6 weeks of training, only persons in experimental group
Secondary	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
Secondary	Modified Fatigue Impact Scale (MFIS)	Evaluation of fatigue	At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Secondary	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
Secondary	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
Secondary	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