Implementation of a Rehabilitation Technology in Orthopedic and Neurological Rehabilitation to Increase Therapy Dosage: an Exploratory Study

Phase 1

• Conditions: Arthroplasty; Neurologic Disorder
• Interventions: Device: i-ACT

• Registration Number: NCT04906681
• Lead Sponsor: PXL University College

Brief Summary

Rehabilitation technology is more and more implemented in conventional therapy to increase the dosage of therapy and/or increase patient's motivation towards therapy. In orthopedic as well as neurological rehabilitation it is important to exercise with enough intensity and repetitions to improve functional performance in activities of daily life, and consequently quality of life. At the moment, not all (rehabilitation) technologies are adapted towards the wishes and needs of both patients and therapists for everyday use in the clinical setting. Also, not all technologies are fit for independent use by the patients. Researcher of PXL have developed a Kinect-based system (i.e. i-ACT) for rehabilitation and performed supervised research with i-ACT in neurological and musculoskeletal rehabilitation, and older adults. Within this research, patients will exercise with i-ACT under supervision of their therapist during weekdays, but in the weekends they will be motivated by the medical staff to perform their exercises with i-ACT. The medical staff will be present for safety reasons, but the patient is asked to use and exercise with i-ACT as independent as possible. The aim of this research is to explore to which extend i-ACT is suitable for semi-independent use by patients in orthopedic or neurological rehabilitation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-05-28
• Last Update Posted: 2021-06-01
• Study Start: 2021-09-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age over 18 years old
• post-operation of arthroplasty (hip or knee), or official medical diagnosis of stroke or Parkinson's disease
• understand Dutch instructions
• patient at St-Trudo ziekenhuis
• experiencing problems in functional performance

Exclusion Criteria

• neglect
• spasticity (Brunström Fugl-Meyer < 50)
• cognitive disfunction (Mini Mental State Examination < 24)
• visual impairment (blind, cataract, etc.)
• persons who are not able to exit electric wheelchair

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroplasty, hip or knee	i-ACT	Minimum 5x/week (of which minimal 3x/week with therapists and 2x/week during weekend), 30-60 minutes training, for 4 weeks, with i-ACT system. i-ACT provides individualised exercises based on patients own goalsetting.
Neurology: stroke or Parkinson disease	i-ACT	Minimum 5x/week (of which minimal 3x/week with therapists and 2x/week during weekend), 30-60 minutes training, for 4 weeks, with i-ACT system. i-ACT provides individualised exercises based on patients own goalsetting.

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure	4 weeks	The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time. Scores range from 0 to 10 (best score) in each defined goal.

Secondary Outcome Measures

Name	Time	Method
2 Minute Walking Test	4 weeks	This is a measure of the distance a person can walk in 2 minutes.
Intrinsic Motivation Inventory	4 weeks	The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement questionnaire intended to assess participants' subjective experience with, in this, i-ACT. The IMI consists of 6 subscales in which a person scores on a scale from 1 (totally not true) to 7 (totally true). Some scores need to be reversed by subtracting the response score from 8. A total IMI-score is not recommended, therefore subscale scores are used in the analyses. A higher score means a higher level of the aspect of the subscale.
Wolf Motor Function Test	4 weeks	Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Barthel Index	4 weeks	The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL. Scores range from 0 to 100.
System Usability Scale	4 weeks	Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Timed Up and Go test	4 weeks	The time between a person standing up from a chair, walking 3 meters before turning around and walking back to sit back in the chair.