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

NCT04906681 | Unknown Phase 1 FDA Device

• 1 other identifier: Exploration in St-Trudo
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroplasty; Neurologic Disorder

Keywords

rehabilitation; technology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Intrinsic Motivation Inventory

  1 week

• Intrinsic Motivation Inventory

  4 weeks

• System Usability Scale

  1 week

• System Usability Scale

  4 weeks

• Timed Up and Go test

  Baseline

Study Arms (2)

Arthroplasty, hip or knee

EXPERIMENTAL

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

Neurology: stroke or Parkinson disease

EXPERIMENTAL

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

Interventions

i-ACT DEVICE

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

Arthroplasty, hip or knee; Neurology: stroke or Parkinson disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PXL University College: lead
• St-Trudo hospital, St-Truiden, Belgium: collaborator

MeSH Terms

Conditions

Nervous System Diseases

Central Study Contacts

Els Knippenberg, MSc

CONTACT

+3211775225; els.knippenberg@pxl.be

Fitore Bajrami, BSc

CONTACT

011 69 91 11; fitore.bajrami@stzh.be

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: May 28, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 3 months after publication.