StrokeNCT05315089
Effects and Perception of Intensive Virtual Reality Training on Upper Limb Functions After Stroke
A study testing Virtual reality games +conventional exercises and Conventional exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Previous literature review shows limited work on upper limb recovery from Virtual Reality device and most of them are pilot studies meta-analysis some Randomized control Trial studies are done but this study will cover mixed method including both qualitative and quantitative method. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual reality games +conventional exercises and Conventional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 30 Dec 2022
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1- Subacute and chronic stroke patient > 3 months post stroke till 1 year. 2. Both gender 3. Age: 40-70 years 4. Modified Ashworth scale1-3 5. MMSE>25 6. Able to follow verbal instructions related to the use of VR devices
Who cannot join
- Neurological disorders other than stroke.
- Aphasia that would limit the ability to follow verbal instructions.
- Participation in other upper extremity therapies during the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Misbah Ghous
Rawalpindi, Punjab Province, 46000
Misbah Ghous, 03086152722, drmisbahghous@gmail.com
About this study
Previous literature review shows limited work on upper limb recovery from Virtual Reality device and most of them are pilot studies meta-analysis some Randomized control Trial studies are done but this study will cover mixed method including both qualitative and quantitative method.
Read the detailed description
Stroke is the leading cause of disability worldwide Approximately 80% of stroke survivors regain ability to walk, 30 - 66% of survivors are not able to use their affected upper limb mobility. With improving survival rates and longer life expectancy in general, the burden of caring for stroke survivors is likely to increase. As a lack of upper limb recovery results in significant dependence and a reduced quality of life. Persistent upper limb (UL) dysfunction after a stroke is one of the most challenging issues in rehabilitation. Effective upper limb treatment interventions have therefore been identified as a priority for stroke research. One of the rehabilitation strategies include performing self-administered exercises using VR games technology. Effective treatment interventions post-stroke is characterized by high intensity and repetitive practice of a meaningful task. However, changes in infrastructure, an emphasis on mobility during early rehabilitation ,to reduce hospital length of stay and a lack of therapy on discharge home have resulted in challenges delivering the amount of rehabilitation necessary to optimize recovery. A promising technique, which has the capability of creating an interactive environment in which practice intensity and feedback can be manipulated to retrain movement in the upper limb in people with stroke, is virtual reality (VR) technology .VR provides a sense of illusion: of being immersed in a world where objects can he visualized and interact with. The system is usually a controlled one, where the objects and interaction styles (point, touch, grasp) are defined prior to the controlling program being executed. There are a number of ways in which the virtual environment (VE) can he presented to the user. Most common are desktop (fish tank) VR systems where the VE is displayed on a standard desktop monitor. The user can interact with the environment via standard hardware (keyboard, mouse) or via specialized VR devices such as data gloves, hut is conscious of 'looking at' the environment rather than 'immersed in' the environment.
- Conditions
- Stroke
- Being tested
- Virtual reality games +conventional exercises, Conventional exercises
- Keywords
- intensive virtual reality, upper limb functions
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality games +conventional exercisesOther
Virtual reality games +conventional exercises
Conventional exercisesOther
Conventional exercises
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Virtual reality games +conventional exercises Receives: Other: Virtual reality games +conventional exercises |
| control Group | Active comparator | Conventional exercises Receives: Other: Conventional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl- Meyer assessment upper extremity
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Measured: Change from Baseline , motor functions to 3 Week, to 6 week
Chedoke Arm and Hand Inventory
The Chedoke Arm and Hand Activity Inventory (CAHAI) is a functional assessment of the recovering arm and hand after stroke
Measured: Change from Baseline , motor functions of hand to 3 Week, to 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah college of Rehabilitation and Allied Health sciences Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315089
- Sponsor's protocol ID
- REC/01245 Iqra Butt
- Status last verified
- May 2022
- First submitted
- 30 Mar 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hughes AM, Burridge JH, Demain SH, Ellis-Hill C, Meagher C, Tedesco-Triccas L, Turk R, Swain I. Translation of evidence-based Assistive Technologies into stroke rehabilitation: users' perceptions of the barriers and opportunities. BMC Health Serv Res. 2014 Mar 12;14:124. doi: 10.1186/1472-6963-14-124.
PubMed 24620739Ward N, Kelly K, Brander F. The future of stroke rehabilitation: upper limb recovery. ACNR. 2015;15(4):6-8.
Elnady A, Mortenson WB, Menon C. Perceptions of Existing Wearable Robotic Devices for Upper Extremity and Suggestions for Their Development: Findings From Therapists and People With Stroke. JMIR Rehabil Assist Technol. 2018 May 15;5(1):e12. doi: 10.2196/rehab.9535.
PubMed 29764799Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.
PubMed 24681826Khalid I, Ghous M, Mehmood Q, Malik AN, Jahn S. Effects and perception of intensive exergaming training on upper limb functions after stroke: mixed method study. Top Stroke Rehabil. 2026 Aug 30:1-13. doi: 10.1080/10749357.2026.2723406. Online ahead of print.
PubMed 42669200
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Perception of Intensive Virtual Reality Training on Upper Limb Functions After Stroke
- ClinicalTrials.gov ID
- NCT05315089
- Acronym / sponsor ID
- REC/01245 Iqra Butt
- Conditions
- Stroke
- Keywords
- intensive virtual reality, upper limb functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 7 Apr 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.
Previous literature review shows limited work on upper limb recovery from Virtual Reality device and most of them are pilot studies meta-analysis some Randomized control Trial studies are done but this study will cover mixed method including both qualitative and quantitative method.
Detailed description
Stroke is the leading cause of disability worldwide Approximately 80% of stroke survivors regain ability to walk, 30 - 66% of survivors are not able to use their affected upper limb mobility. With improving survival rates and longer life expectancy in general, the burden of caring for stroke survivors is likely to increase. As a lack of upper limb recovery results in significant dependence and a reduced quality of life. Persistent upper limb (UL) dysfunction after a stroke is one of the most challenging issues in rehabilitation. Effective upper limb treatment interventions have therefore been identified as a priority for stroke research. One of the rehabilitation strategies include performing self-administered exercises using VR games technology. Effective treatment interventions post-stroke is characterized by high intensity and repetitive practice of a meaningful task. However, changes in infrastructure, an emphasis on mobility during early rehabilitation ,to reduce hospital length of stay and a lack of therapy on discharge home have resulted in challenges delivering the amount of rehabilitation necessary to optimize recovery. A promising technique, which has the capability of creating an interactive environment in which practice intensity and feedback can be manipulated to retrain movement in the upper limb in people with stroke, is virtual reality (VR) technology .VR provides a sense of illusion: of being immersed in a world where objects can he visualized and interact with. The system is usually a controlled one, where the objects and interaction styles (point, touch, grasp) are defined prior to the controlling program being executed. There are a number of ways in which the virtual environment (VE) can he presented to the user. Most common are desktop (fish tank) VR systems where the VE is displayed on a standard desktop monitor. The user can interact with the environment via standard hardware (keyboard, mouse) or via specialized VR devices such as data gloves, hut is conscious of 'looking at' the environment rather than 'immersed in' the environment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Virtual reality games +conventional exercisesVirtual reality games +conventional exercises |
| control Group | Active comparator | Other: Conventional exercisesConventional exercises |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1- Subacute and chronic stroke patient > 3 months post stroke till 1 year. 2. Both gender 3. Age: 40-70 years 4. Modified Ashworth scale1-3 5. MMSE>25 6. Able to follow verbal instructions related to the use of VR devices
Key exclusion criteria (3 listed)
- Neurological disorders other than stroke.
- Aphasia that would limit the ability to follow verbal instructions.
- Participation in other upper extremity therapies during the study
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 games +conventional exercisesVirtual reality games +conventional exercises | Other | Interventional Group |
| Conventional exercisesConventional exercises | Other | control Group |
Primary outcome
Fugl- Meyer assessment upper extremity
Time frame: Change from Baseline , motor functions to 3 Week, to 6 week
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Chedoke Arm and Hand Inventory
Time frame: Change from Baseline , motor functions of hand to 3 Week, to 6 week
The Chedoke Arm and Hand Activity Inventory (CAHAI) is a functional assessment of the recovering arm and hand after stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 24620739Hughes AM, Burridge JH, Demain SH, Ellis-Hill C, Meagher C, Tedesco-Triccas L, Turk R, Swain I. Translation of evidence-based Assistive Technologies into stroke rehabilitation: users' perceptions of the barriers and opportunities. BMC Health Serv Res. 2014 Mar 12;14:124. doi: 10.1186/1472-6963-14-124.
- BackgroundWard N, Kelly K, Brander F. The future of stroke rehabilitation: upper limb recovery. ACNR. 2015;15(4):6-8.
- Background: PubMed 29764799Elnady A, Mortenson WB, Menon C. Perceptions of Existing Wearable Robotic Devices for Upper Extremity and Suggestions for Their Development: Findings From Therapists and People With Stroke. JMIR Rehabil Assist Technol. 2018 May 15;5(1):e12. doi: 10.2196/rehab.9535.
- Background: PubMed 24681826Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.
- Derived from this study: PubMed 42669200Khalid I, Ghous M, Mehmood Q, Malik AN, Jahn S. Effects and perception of intensive exergaming training on upper limb functions after stroke: mixed method study. Top Stroke Rehabil. 2026 Aug 30:1-13. doi: 10.1080/10749357.2026.2723406. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Misbah Ghous, MSNMPT principal investigator
Riphah college of Rehabilitation and Allied Health sciences Islamabad
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 games +conventional exercises and Conventional exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 3 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 17 May 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl- Meyer assessment upper extremity (time frame: Change from Baseline , motor functions to 3 Week, to 6 week). 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?
On the ClinicalTrials.gov record for NCT05315089, which also lists 5 linked publications.
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 17 May 2022.