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Completed

NCT Number: NCT02982811

Intelligent Activity-based Client-centred Training

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.).

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Key information

Conditions

Central Nervous System Diseases Aged Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

i-ACT

Device

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.)

Primary outcomes

  1. Wolf Motor Function Test (WMFT)

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

    Evaluation of upper extremity

  2. Short Form 36 (SF-36)

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

    Evaluation of general health status and quality of life

Secondary outcomes

  1. Intrinsic Motivation Inventory (IMI)

    Time frame: After 6 weeks of training, only persons in experimental group

    Evaluation of motivation towards using the system in neurorehabilitation

  2. Manual Ability Measure (MAM-36)

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

    Evaluation of performance of manual tasks

  3. Modified Fatigue Impact Scale (MFIS)

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

    Evaluation of fatigue

  4. Trunk Impairment Scale (TIS)

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

    Evaluation of sitting, standing and core stability

  5. Active Range of Motion (AROM)

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

    Evaluation of active range of motion

  6. Canadian Occupational Performance Measure (COPM)

    Time frame: At baseline, after 6 weeks of training, and 6 weeks follow-up

    Evaluation of self-perception of performance of ADL tasks

Sponsors and collaborators

Lead sponsor

PXL University College

Other

Collaborators

  • Hasselt University
  • Revalidatie & MS Centrum Overpelt
  • Ziekenhuis Oost-Limburg

Registry information

Acronym: i-ACT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2016
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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