NCT02982811

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.).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

November 29, 2016

Last Update Submit

July 23, 2020

Conditions

Central Nervous System DiseasesAged

Keywords

Activity-basedClient-centredRehabilitationQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Intrinsic Motivation Inventory (IMI)

    After 6 weeks of training, only persons in experimental group

  • Manual Ability Measure (MAM-36)

    At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up

  • Modified Fatigue Impact Scale (MFIS)

    At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up

  • Trunk Impairment Scale (TIS)

    At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up

  • Active Range of Motion (AROM)

    At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up

  • +1 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Therapy as usual, i.e. occupational therapy, physiotherapy, etc.

Experimental group

EXPERIMENTAL

Therapy as usual together with 3x45min training with i-ACT system during 6 weeks.

Device: i-ACT

Interventions

i-ACTDEVICE

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.)

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jessa Hospital - rehabilitation campus St-Ursula

Herk-de-Stad, Limburg, 3540, Belgium

Location

Ziekenhuis Oost Limburg

Lanaken, Limburg, 3620, Belgium

Location

Revalidatie en MS centrum

Overpelt, Limburg, 3900, Belgium

Location

St-Trudo hospital

Sint-Truiden, Limburg, 3800, Belgium

Location

Related Publications (1)

  • Knippenberg E, Timmermans A, Coolen J, Neven K, Hallet P, Lemmens J, Spooren A. Efficacy of a technology-based client-centred training system in neurological rehabilitation: a randomised controlled trial. J Neuroeng Rehabil. 2021 Dec 28;18(1):184. doi: 10.1186/s12984-021-00977-2.

    PMID: 34961531DERIVED

MeSH Terms

Conditions

Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Annemie Spooren, Prof. Dr.

    Centre of Expertise - Innovation in Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher and PhD student

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 5, 2016

Study Start

March 1, 2017

Primary Completion

May 31, 2020

Study Completion

June 26, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(4)