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Intelligent Activity-based Client-centred Training (i-ACT)

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ClinicalTrials.gov Identifier: NCT02982811
Recruitment Status : Not yet recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborators:
Revalidatie & MS Centrum Overpelt
Adelante, Centre of Expertise in Rehabilitation and Audiology
Information provided by (Responsible Party):
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.).

Condition or disease Intervention/treatment Phase
Central Nervous System Diseases Aged Device: i-ACT Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intelligent Activity-based Client-centred Training
Study Start Date : March 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Therapy as usual, i.e. occupational therapy, physiotherapy, etc.
Experimental: Experimental group
Therapy as usual together with 3x45min training with i-ACT system during 6 weeks.
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.)




Primary Outcome Measures :
  1. Change in Wolf Motor Function Test (WMFT) [ Time Frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up ]
  2. Change in Manual Ability Measure (MAM-36) [ Time Frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up ]
  3. Change in Modified Fatigue Impact Scale (MFIS) [ Time Frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up ]
  4. Change in Trunk Impairment Scale (TIS) [ Time Frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up ]
  5. Change in Active Range of Motion (AROM) [ Time Frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up ]
  6. Change in Short Form 36 (SF-36) [ Time Frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up ]
  7. Change in Canadian Occupational Performance Measure (COPM) [ Time Frame: At baseline, after 6 weeks of training, and 6 weeks follow-up ]

Secondary Outcome Measures :
  1. Intrinsic Motivation Inventory (IMI) [ Time Frame: After 6 weeks of training ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982811


Contacts
Contact: Els Knippenberg, MSc +3211775225 els.knippenberg@pxl.be

Sponsors and Collaborators
PXL University College
Revalidatie & MS Centrum Overpelt
Adelante, Centre of Expertise in Rehabilitation and Audiology
Investigators
Study Director: Annemie Spooren, Prof. Dr. Centre of Expertise - Innovation in Care

Responsible Party: PXL University College
ClinicalTrials.gov Identifier: NCT02982811     History of Changes
Other Study ID Numbers: i-ACT2
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by PXL University College:
Activity-based
Client-centred
Rehabilitation
Quality of life

Additional relevant MeSH terms:
Nervous System Diseases
Central Nervous System Diseases