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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthroplasty; Neurologic Disorder
• Intervention / Treatment: Device: i-ACT

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Els Knippenberg, MSc; Phone Number: +3211775225; Email: els.knippenberg@pxl.be
• Study Contact Backup: Name: Fitore Bajrami, BSc; Phone Number: 011 69 91 11; Email: fitore.bajrami@stzh.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arthroplasty, hip or knee; 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.	Device: i-ACT; i-ACT is a Microsoft Kinect-based system that provides individualised exercises based on patients own goalsetting.
Experimental: Neurology: stroke or Parkinson disease; 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.	Device: i-ACT; i-ACT is a Microsoft Kinect-based system that provides individualised exercises based on patients own goalsetting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Occupational Performance Measure	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.	Baseline
Canadian Occupational Performance Measure	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale	Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).	4 weeks
Wolf Motor Function Test	Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).	Baseline
Wolf Motor Function Test	Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).	4 weeks
Intrinsic Motivation Inventory	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.	1 week
Intrinsic Motivation Inventory	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.	4 weeks
System Usability Scale	Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).	1 week
Timed Up and Go test	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.	Baseline
Timed Up and Go test	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.	4 weeks
2 Minute Walking Test	This is a measure of the distance a person can walk in 2 minutes.	Baseline
2 Minute Walking Test	This is a measure of the distance a person can walk in 2 minutes.	4 weeks
Barthel Index	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.	Baseline
Barthel Index	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.	4 weeks

Collaborators and Investigators

• Sponsor: PXL University College
• Collaborators: St-Trudo hospital, St-Truiden, Belgium

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; technology
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: Exploration in St-Trudo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD that underlie results in a possible publication will be shared.
• IPD Sharing Time Frame: Starting 3 months after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes