Upper Limb InjuryNCT05272436
Using Virtual Reality for Rehabilitation of Upper Limbs at Home Trial
A study testing Virtual Reality Upper Limb Motor Impairment Rehabilitation in people with Upper Limb Injury and Virtual Reality, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
The IVR games have been enhanced to include more levels. The new aspects to be tested in this study are new IVR exercises that would be made upper limb rehab designed for children for home use, as repeated sessions with progression through different levels could improve the prospect of good functional recovery. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Upper Limb Injury, Virtual Reality, Rehabilitation
- What is being tested?
- Virtual Reality Upper Limb Motor Impairment Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 6 Jun 2021
- Phase
- Interventional
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 7-16
- upper limb injuries, for which they are receiving rehabilitative care
- able to speak and understand English.
Who cannot join
- injuries to the face or head that could hinder the correct positioning of the headset or pose an infection risk;
- A learning impairment that could hinder the understanding of the task;
- A history of severe motion sickness;
- Mental health problems;
- Inability to speak and understand English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based Immersive Virtual Reality Physical Rehabilitation in Paediatric Patients for Upper Limb Motor Impairment
The IVR games have been enhanced to include more levels. The new aspects to be tested in this study are new IVR exercises that would be made upper limb rehab designed for children for home use, as repeated sessions with progression through different levels could improve the prospect of good functional recovery. A new wireless headset has recently become available, which will enable the IVR to be run without the need for separate equipment, thereby making home use possible as no complicated set-up will be required.
This project aims to explore the feasibility, acceptability and perceived effectiveness of an improved suite of Immersive Virtual Reality (IVR) system suitable for Upper Limb Motor Impairment (ULMI) rehabilitation for children at home. A multidirectional perspective has been adopted, including patients, caregivers, and clinical staff.
Read more
The aims and objectives of the clinical feasibility trial are:
- to investigate the potential of IVR for ULMI rehabilitation (range of motion recovery) at home compared to usual physical therapy in a small sample of paediatric patients.
- to measure the impact of the interventions from a mixed methods (quantitative and qualitative) and a multidirectional perspective (patients, clinicians, family members).
Read the detailed description
This project builds upon a previous MRC 'Confidence in Concept' feasibility project which developed Virtual Reality (VR) games for participants at Sheffield Children's Hospital to do arm rehabilitation movements such that they become so engrossed in the IVR they become much less aware of any pain or discomfort linked to the exercises.
Patients (and carer where appropriate) would be involved in the design of the scenarios, the protocol, patient information sheets, and the project steering group. Research nurses will download anonymised usage data from the VR headset used at home and interview participants. All data will feed into an evaluation which will demonstrate the concept and acceptability of using IVR at home.
Procedure Patients usually have a 20-30 minutes appointment during which the OT/PT reviews their previously prescribed home exercise regime with them, measures ROM, and explains and discusses new home exercises. For the purpose of the trial, patients had their usual OT/PT appointments but were asked to use the IVR games to do the prescribed home exercises. Before consenting to participate, each patient was offered a 5-10 minute experience of the game to familiarise themselves with how it worked and to check for problems. Written and verbal consents were taken from parents and children.
The pre-trial PedsQL was administered in the initial OT/PT appointment. Children were then asked to use the IVR system for approximately 15 minutes twice a day. Trial participation lasted three weeks during the prescribed treatment weeks.
Following the at-home trial, patients and parents returned the equipment to the clinic in the final appointment and the SUS and the post-trial Peds QL were administrated by OT/PT in person. In addition, they participated in semi-structured interviews as described above.
At the end of the trial, an interview (10 minutes) with the OT was conducted by a research nurse.
- Conditions
- Upper Limb Injury, Virtual Reality, Rehabilitation, Paediatric
- Being tested
- Virtual Reality Upper Limb Motor Impairment Rehabilitation
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Upper Limb Motor Impairment RehabilitationDevice
Also called No intervention
Patients wore a VR headset while undergoing their physical rehabilitation at home
| Study group | Role | What they receive |
|---|---|---|
| Patients IVR for Upper Limb Motor Impairment Rehabilitation in children and at home trial | Experimental | For the purpose of the trial, patients had their usual OT/PT appointments but were asked to use the IVR games to do the prescribed home exercises. Before consenting to participate, each patient was offered a 5-10 minute experience of the game to familiarise themselves with how it worked and to check for problems. Written and verbal consents were taken from parents and children.
The pre-trial PedsQL was administered in the initial OT/PT appointment. Children were then asked to use the IVR system for approximately 15 minutes twice a day. Trial participation lasted three weeks during the prescribed treatment weeks.
Following the at-home trial, patients and parents returned the equipment to the clinic in the final appointment and the SUS and the post-trial Peds QL were administrated by OT/PT in person. In addition, they participated in semi-structured interviews as described above. Receives: Device: Virtual Reality Upper Limb Motor Impairment Rehabilitation |
| Occupational Therapist perceptions of the effectiveness of the IVR | Other | She recruited the patients, gave out devices, administered the outcome measures and provided us with feedback about their experience with the VR game.
At the end of the trial, an interview (10 minutes) with the OT was conducted by a research nurse. Receives: Device: Virtual Reality Upper Limb Motor Impairment Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of child participant's movement during physiotherapy sessions: Goniometer (Standard BASELINE® 12-inch)
Goniometer device (Standard BASELINE® 12-inch plastic goniometer, (Model 12-1000-Fabrication Enter- prises, Inc: White Plains, New York) was used by the clinical staff before and after the patient's rehabilitation to document the initial and subsequent range of motion, evaluate their progress and to determine the level of disability. We used the goniometer, to assess the physical therapy effectiveness of the VR rehabilitation and to personalize the system's range of motion for each patient. We examined the differences between a range of movements limb join (flexion, extension, abduction, and adduction) before and after the VR rehabilitation. The greater the range of movement the better.
Measured: Three weeks
Paediatric Quality of Life Inventory (PedsQL) (Version 4.0 - UK English) results
PedsQL is a standardised assessment for children aged 5-18 and was completed by patients before and after the IVR rehabilitation at-home trial. The scale features twenty-three items representing five dimensions: Physical, Emotional, Social, and School Functioning (e.g., physical functioning (problems with...) walking 100 metres; emotional functioning (problems with...) feeling afraid or scared; social functioning (problems with...) getting along with other children; and school functioning (problems with...) paying attention in class). The instructions ask how much of a problem each item has been in the past month, and responses are on a five-point scale ranging from 0 (never a problem) to 4 (almost always a problem) (Upton et al., 2005).
Measured: Three weeks
System Usability Scale (SUS) results
System Usability Scale SUS) is a quantitative scale to measure system usability was completed by patients after the IVR rehabilitation at-home trial. It consists of a 10 item with 5-point response options from Strongly agree to Strongly disagree (Brooke, 1996). The scale evaluates the perceived ease of use (a single dimension). However, recent research shows that items 4 and 10 could provide the learnability dimension. Score contribution of each item was coded from 0 to 4 (items with positive words 1, 3, 5, 7 and 9; items with negative words 2, 4, 6, 8 and 10), and the sum of the contributions of the item scores was multiplied by 2.5 to obtain the overall SUS score (0 to 100). Scores were analysed above or below the standard mean score of 68. A score close to 100 was considered good usability of the system.
Measured: Three weeks
Interview Qualitative Results, Perceptions, Usability and Effectiveness of IVR system in ULMI rehab in children at home
Semi-structured interviews were conducted by the research nurse in person (Pt 1, 4, 6, 7) and by phone (Pt 2, 3, 8) with patients and parents after the IVR rehabilitation at-home trial. Open-ended questions provided qualitative data relating to difficulty, pain and enjoyability, and participant attitudes towards the IVR system and its future deployment. Another semi-structured interview was conducted with the OT by the research nurse in person at the end of the trial to explore her attitudes towards the IVR system and future VR deployment. Both interviews were recorded, transcribed and anonymised.
Measured: Three weeks
Interview Quantitative Results, Perceptions, Usability and Effectiveness of IVR system in ULMI rehab in children at home
During the semi-structured interview four ad-hoc closed ten-point Likert questions were asked. These provided a quantitative measure of the perceived ease or difficulty of use, pain levels and enjoyability of the IVR system.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Jun 2020
- Primary completion6 Jun 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb InjuryStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study aimed to explore: * patients, clinicians, family members perceptions of the effect of IVR on ULMI rehabilitation (range of movement (ROM) recovery) * patient perceptions of the usability, quality of live, acceptability, engagement with and enjoyment of IVR scenarios; * occupational therapies perceptions about the usability and implications of the IVR technology within a patient rehabilitation at home. Methods: This was a small-scale mixed methods (quantitative and qualitative) study. Patients: paediatric patients recruited from Sheffield Children's Foundation Hospital Trust in England, UK, their parents, and an occupational therapist (OT) from the Sheffield Children's Foundation Hospital Trust for Burns, Plastics, and Orthopaedics participated in the study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272436
- Sponsor's protocol ID
- AA14673868
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phelan I, Carrion-Plaza A, Furness PJ, Dimitri P. Home-based immersive virtual reality physical rehabilitation in paediatric patients for upper limb motor impairment: a feasibility study. Virtual Real. 2023;27(4):3505-3520. doi: 10.1007/s10055-023-00747-6. Epub 2023 Jan 14.
PubMed 36686613
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Immersive Virtual Reality Physical Rehabilitation in Paediatric Patients for Upper Limb Motor Impairment
- ClinicalTrials.gov ID
- NCT05272436
- Acronym / sponsor ID
- AA14673868
- Conditions
- Upper Limb Injury, Virtual Reality, Rehabilitation, Paediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 9 Mar 2022 (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.
The IVR games have been enhanced to include more levels. The new aspects to be tested in this study are new IVR exercises that would be made upper limb rehab designed for children for home use, as repeated sessions with progression through different levels could improve the prospect of good functional recovery. A new wireless headset has recently become available, which will enable the IVR to be run without the need for separate equipment, thereby making home use possible as no complicated set-up will be required.
This project aims to explore the feasibility, acceptability and perceived effectiveness of an improved suite of Immersive Virtual Reality (IVR) system suitable for Upper Limb Motor Impairment (ULMI) rehabilitation for children at home. A multidirectional perspective has been adopted, including patients, caregivers, and clinical staff.
The aims and objectives of the clinical feasibility trial are:
- to investigate the potential of IVR for ULMI rehabilitation (range of motion recovery) at home compared to usual physical therapy in a small sample of paediatric patients.
- to measure the impact of the interventions from a mixed methods (quantitative and qualitative) and a multidirectional perspective (patients, clinicians, family members).
Detailed description
This project builds upon a previous MRC 'Confidence in Concept' feasibility project which developed Virtual Reality (VR) games for participants at Sheffield Children's Hospital to do arm rehabilitation movements such that they become so engrossed in the IVR they become much less aware of any pain or discomfort linked to the exercises.
Patients (and carer where appropriate) would be involved in the design of the scenarios, the protocol, patient information sheets, and the project steering group. Research nurses will download anonymised usage data from the VR headset used at home and interview participants. All data will feed into an evaluation which will demonstrate the concept and acceptability of using IVR at home.
Procedure Patients usually have a 20-30 minutes appointment during which the OT/PT reviews their previously prescribed home exercise regime with them, measures ROM, and explains and discusses new home exercises. For the purpose of the trial, patients had their usual OT/PT appointments but were asked to use the IVR games to do the prescribed home exercises. Before consenting to participate, each patient was offered a 5-10 minute experience of the game to familiarise themselves with how it worked and to check for problems. Written and verbal consents were taken from parents and children.
The pre-trial PedsQL was administered in the initial OT/PT appointment. Children were then asked to use the IVR system for approximately 15 minutes twice a day. Trial participation lasted three weeks during the prescribed treatment weeks.
Following the at-home trial, patients and parents returned the equipment to the clinic in the final appointment and the SUS and the post-trial Peds QL were administrated by OT/PT in person. In addition, they participated in semi-structured interviews as described above.
At the end of the trial, an interview (10 minutes) with the OT was conducted by a research nurse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study aimed to explore: * patients, clinicians, family members perceptions of the effect of IVR on ULMI rehabilitation (range of movement (ROM) recovery) * patient perceptions of the usability, quality of live, acceptability, engagement with and enjoyment of IVR scenarios; * occupational therapies perceptions about the usability and implications of the IVR technology within a patient rehabilitation at home. Methods: This was a small-scale mixed methods (quantitative and qualitative) study. Patients: paediatric patients recruited from Sheffield Children's Foundation Hospital Trust in England, UK, their parents, and an occupational therapist (OT) from the Sheffield Children's Foundation Hospital Trust for Burns, Plastics, and Orthopaedics participated in the study
| Arm | Type | Receives |
|---|---|---|
| Patients IVR for Upper Limb Motor Impairment Rehabilitation in children and at home trial | Experimental | Device: Virtual Reality Upper Limb Motor Impairment RehabilitationFor the purpose of the trial, patients had their usual OT/PT appointments but were asked to use the IVR games to do the prescribed home exercises. Before consenting to participate, each patient was offered a 5-10 minute experience of the game to familiarise themselves with how it worked and to check for problems. Written and verbal consents were taken from parents and children. The pre-trial PedsQL was administered in the initial OT/PT appointment. Children were then asked to use the IVR system for approximately 15 minutes twice a day. Trial participation lasted three weeks during the prescribed treatment weeks. Following the at-home trial, patients and parents returned the equipment to the clinic in the final appointment and the SUS and the post-trial Peds QL were administrated by OT/PT in person. In addition, they participated in semi-structured interviews as described above. |
| Occupational Therapist perceptions of the effectiveness of the IVR | Other | Device: Virtual Reality Upper Limb Motor Impairment RehabilitationShe recruited the patients, gave out devices, administered the outcome measures and provided us with feedback about their experience with the VR game. At the end of the trial, an interview (10 minutes) with the OT was conducted by a research nurse. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- aged 7-16
- upper limb injuries, for which they are receiving rehabilitative care
- able to speak and understand English.
Key exclusion criteria (5 listed)
- injuries to the face or head that could hinder the correct positioning of the headset or pose an infection risk;
- A learning impairment that could hinder the understanding of the task;
- A history of severe motion sickness;
- Mental health problems;
- Inability to speak and understand English.
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 |
|---|---|---|
| Virtual Reality Upper Limb Motor Impairment RehabilitationAlso: No interventionPatients wore a VR headset while undergoing their physical rehabilitation at home | Device | Occupational Therapist perceptions of the effectiveness of the IVR, Patients IVR for Upper Limb Motor Impairment Rehabilitation in children and at home trial |
Primary outcome
Ratings of child participant's movement during physiotherapy sessions: Goniometer (Standard BASELINE® 12-inch)
Time frame: Three weeks
Goniometer device (Standard BASELINE® 12-inch plastic goniometer, (Model 12-1000-Fabrication Enter- prises, Inc: White Plains, New York) was used by the clinical staff before and after the patient's rehabilitation to document the initial and subsequent range of motion, evaluate their progress and to determine the level of disability. We used the goniometer, to assess the physical therapy effectiveness of the VR rehabilitation and to personalize the system's range of motion for each patient. We examined the differences between a range of movements limb join (flexion, extension, abduction, and adduction) before and after the VR rehabilitation. The greater the range of movement the better.
Paediatric Quality of Life Inventory (PedsQL) (Version 4.0 - UK English) results
Time frame: Three weeks
PedsQL is a standardised assessment for children aged 5-18 and was completed by patients before and after the IVR rehabilitation at-home trial. The scale features twenty-three items representing five dimensions: Physical, Emotional, Social, and School Functioning (e.g., physical functioning (problems with...) walking 100 metres; emotional functioning (problems with...) feeling afraid or scared; social functioning (problems with...) getting along with other children; and school functioning (problems with...) paying attention in class). The instructions ask how much of a problem each item has been in the past month, and responses are on a five-point scale ranging from 0 (never a problem) to 4 (almost always a problem) (Upton et al., 2005).
System Usability Scale (SUS) results
Time frame: Three weeks
System Usability Scale SUS) is a quantitative scale to measure system usability was completed by patients after the IVR rehabilitation at-home trial. It consists of a 10 item with 5-point response options from Strongly agree to Strongly disagree (Brooke, 1996). The scale evaluates the perceived ease of use (a single dimension). However, recent research shows that items 4 and 10 could provide the learnability dimension. Score contribution of each item was coded from 0 to 4 (items with positive words 1, 3, 5, 7 and 9; items with negative words 2, 4, 6, 8 and 10), and the sum of the contributions of the item scores was multiplied by 2.5 to obtain the overall SUS score (0 to 100). Scores were analysed above or below the standard mean score of 68. A score close to 100 was considered good usability of the system.
Interview Qualitative Results, Perceptions, Usability and Effectiveness of IVR system in ULMI rehab in children at home
Time frame: Three weeks
Semi-structured interviews were conducted by the research nurse in person (Pt 1, 4, 6, 7) and by phone (Pt 2, 3, 8) with patients and parents after the IVR rehabilitation at-home trial. Open-ended questions provided qualitative data relating to difficulty, pain and enjoyability, and participant attitudes towards the IVR system and its future deployment. Another semi-structured interview was conducted with the OT by the research nurse in person at the end of the trial to explore her attitudes towards the IVR system and future VR deployment. Both interviews were recorded, transcribed and anonymised.
Interview Quantitative Results, Perceptions, Usability and Effectiveness of IVR system in ULMI rehab in children at home
Time frame: Three weeks
During the semi-structured interview four ad-hoc closed ten-point Likert questions were asked. These provided a quantitative measure of the perceived ease or difficulty of use, pain levels and enjoyability of the IVR system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 36686613Phelan I, Carrion-Plaza A, Furness PJ, Dimitri P. Home-based immersive virtual reality physical rehabilitation in paediatric patients for upper limb motor impairment: a feasibility study. Virtual Real. 2023;27(4):3505-3520. doi: 10.1007/s10055-023-00747-6. Epub 2023 Jan 14.
- Individual participant dataSharing planned: No
Related trials for Upper Limb Injury
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Upper Limb Motor Impairment Rehabilitation in people with Upper Limb Injury and Virtual Reality, run by Sheffield Hallam University at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratings of child participant's movement during physiotherapy sessions: Goniometer (Standard BASELINE® 12-inch) (time frame: Three weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272436, which also lists 1 linked publication.
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 9 Mar 2022.