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

Neurologic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04906681
• Other study ID #: Exploration in St-Trudo
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2021
• Source: PXL University College
• Contact: Els Knippenberg, MSc
• Phone: +3211775225
• Email: els.knippenberg[@]pxl.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty
• Nervous System Diseases
• Neurologic Disorder

Intervention

Device:
• i-ACT
i-ACT is a Microsoft Kinect-based system that provides individualised exercises based on patients own goalsetting.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
PXL University College	St-Trudo hospital, St-Truiden, Belgium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	System Usability Scale	Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).	1 week
Secondary	System Usability Scale	Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).	4 weeks
Secondary	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
Secondary	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
Secondary	2 Minute Walking Test	This is a measure of the distance a person can walk in 2 minutes.	Baseline
Secondary	2 Minute Walking Test	This is a measure of the distance a person can walk in 2 minutes.	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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