ArthroplastyPhase 1/2NCT04906681
Implementation of a Rehabilitation Technology in Orthopedic and Neurological Rehabilitation to Increase Therapy Dosage: an Exploratory Study
A Phase 1/2 study testing i-ACT in people with Arthroplasty and Neurologic Disorder, run by PXL University College.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Neurologic Disorder
- What is being tested?
- i-ACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this 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.
- Conditions
- Arthroplasty, Neurologic Disorder
- Being tested
- i-ACT
- Keywords
- rehabilitation, technology
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-ACTDevice
i-ACT is a Microsoft Kinect-based system that provides individualised exercises based on patients own goalsetting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: i-ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 4 weeks
System Usability Scale
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Measured: 1 week
System Usability Scale
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Measured: 4 weeks
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.
Measured: 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.
Measured: 4 weeks
2 Minute Walking Test
This is a measure of the distance a person can walk in 2 minutes.
Measured: Baseline
2 Minute Walking Test
This is a measure of the distance a person can walk in 2 minutes.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PXL University College
- Sponsor type
- University, hospital or other
- Collaborators
- St-Trudo hospital, St-Truiden, Belgium
- Responsible party
- Principal investigator, Els Knippenberg, PXL University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906681
- Sponsor's protocol ID
- Exploration in St-Trudo
- Status last verified
- May 2021
- First submitted
- 26 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected IPD that underlie results in a possible publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Rehabilitation Technology in Orthopedic and Neurological Rehabilitation to Increase Therapy Dosage: an Exploratory Study
- ClinicalTrials.gov ID
- NCT04906681
- Acronym / sponsor ID
- Exploration in St-Trudo
- Conditions
- Arthroplasty, Neurologic Disorder
- Keywords
- rehabilitation, technology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PXL University CollegeUniversity, hospital or other
- Collaborators
- St-Trudo hospital, St-Truiden, Belgium
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroplasty, hip or knee | Experimental | Device: i-ACTMinimum 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 | Experimental | Device: i-ACTMinimum 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-ACTi-ACT is a Microsoft Kinect-based system that provides individualised exercises based on patients own goalsetting. | Device | Arthroplasty, hip or knee, Neurology: stroke or Parkinson disease |
Primary outcome
Canadian Occupational Performance Measure
Time frame: Baseline
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.
Canadian Occupational Performance Measure
Time frame: 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.
12 secondary outcomes
Intrinsic Motivation Inventory
Time frame: 1 week
Intrinsic Motivation Inventory
Time frame: 4 weeks
System Usability Scale
Time frame: 1 week
System Usability Scale
Time frame: 4 weeks
Timed Up and Go test
Time frame: Baseline
Timed Up and Go test
Time frame: 4 weeks
2 Minute Walking Test
Time frame: Baseline
2 Minute Walking Test
Time frame: 4 weeks
Wolf Motor Function Test
Time frame: Baseline
Wolf Motor Function Test
Time frame: 4 weeks
Barthel Index
Time frame: Baseline
Barthel Index
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: Yes. All collected IPD that underlie results in a possible publication will be shared.
Related trials for Arthroplasty
Not yet recruiting
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
Elective Primary THA or TKA
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Active, not recruiting
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing i-ACT in people with Arthroplasty and Neurologic Disorder, run by PXL University College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Els Knippenberg, MSc (+3211775225, els.knippenberg@pxl.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.