Hemiplegic GaitNCT06459570
Efficacy of VR Based Sword Fighting Exercises to Improve Upper Body Movements in Hemiplegic Patients
A study testing Virtual reality based exercises and standard physical therapy in people with Hemiplegic Gait, run by Superior University at 1 site in Pakistan.
Trial summary
this thesis endeavors to shed light on the efficacy of VR-based sword-fighting exercises as a rehabilitation tool for improving upper body movement in hemiplegic patients. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hemiplegic Gait
- What is being tested?
- Virtual reality based exercises and standard physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80 years
- First clinical stroke, ischemic or hemorrhagic, with diagnosis of stroke confirmed on CT/MRI brain scan.
- Less than 6 weeks after stroke onset
- Upper limb weakness of Medical Research Council (MRC) motor power of grade 2-4 motor power in either the shoulder, elbow or the fingers of the hemiplegic upper extremity
- Subject can understand simple instructions and learn
Who cannot join
- Recurrent stroke
- History of epilepsy
- Presence of arthritis or pain in the affected upper limb restricting repetitive exercises
- Severe aphasia or cognitive impairment, or other psychiatric illnesses that limit the ability to participate or give consent.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
this thesis endeavors to shed light on the efficacy of VR-based sword-fighting exercises as a rehabilitation tool for improving upper body movement in hemiplegic patients.
Read the detailed description
By amalgamating clinical insights, technological advancements, and theoretical frameworks, this research aims to contribute to the growing body of knowledge in neurorehabilitation and pave the way for innovative, effective, and engaging interventions to enhance the lives of individuals affected by hemiplegia.
- Conditions
- Hemiplegic Gait
- Being tested
- Virtual reality based exercises, standard physical therapy
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality based exercisesBehavioural
one experimental group with Virtual reality-based exercises. Subjects in the VR-based exercises will receive 12 sessions of the VR-based exercises treatment, administered four times a week over 3 weeks, with each session lasting approximately 60 minutes.
standard physical therapyOther
"Second control group with standard physical therapy and occupational therapy treatment.Subjects in the control group will receive 12 sessions of physical therapy treatment involving passive and active range of motion exercises, muscle strengthening, and therapeutic stretching, administered four times a week over a span of 3 weeks, with each session lasting approximately 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality based exercises | Experimental | Not described Receives: Behavioral: Virtual reality based exercises |
| standard physical therapy | Other | Not described Receives: Other: standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of upper limb (FMA)
This measures upper limb impairment and scores from 0 to 66, the higher the score, the less the impairment. 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: 12 Months
Action Research Arm Test (ARAT)
This measures arm and hand function and ranges from 0 to 57, the higher the score, the better the upper limb function. The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic GaitStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459570
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/729
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of VR Based Sword Fighting Exercises to Improve Upper Body Movements in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT06459570
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/729
- Conditions
- Hemiplegic Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
this thesis endeavors to shed light on the efficacy of VR-based sword-fighting exercises as a rehabilitation tool for improving upper body movement in hemiplegic patients.
Detailed description
By amalgamating clinical insights, technological advancements, and theoretical frameworks, this research aims to contribute to the growing body of knowledge in neurorehabilitation and pave the way for innovative, effective, and engaging interventions to enhance the lives of individuals affected by hemiplegia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality based exercises | Experimental | Behavioral: Virtual reality based exercises |
| standard physical therapy | Other | Other: standard physical therapy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21-80 years
- First clinical stroke, ischemic or hemorrhagic, with diagnosis of stroke confirmed on CT/MRI brain scan.
- Less than 6 weeks after stroke onset
- Upper limb weakness of Medical Research Council (MRC) motor power of grade 2-4 motor power in either the shoulder, elbow or the fingers of the hemiplegic upper extremity
- Subject can understand simple instructions and learn
Key exclusion criteria (4 listed)
- Recurrent stroke
- History of epilepsy
- Presence of arthritis or pain in the affected upper limb restricting repetitive exercises
- Severe aphasia or cognitive impairment, or other psychiatric illnesses that limit the ability to participate or give consent.
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 based exercisesone experimental group with Virtual reality-based exercises. Subjects in the VR-based exercises will receive 12 sessions of the VR-based exercises treatment, administered four times a week over 3 weeks, with each session lasting approximately 60 minutes. | Behavioural | Virtual reality based exercises |
| standard physical therapy"Second control group with standard physical therapy and occupational therapy treatment.Subjects in the control group will receive 12 sessions of physical therapy treatment involving passive and active range of motion exercises, muscle strengthening, and therapeutic stretching, administered four times a week over a span of 3 weeks, with each session lasting approximately 60 minutes. | Other | standard physical therapy |
Primary outcome
Fugl-Meyer Assessment of upper limb (FMA)
Time frame: 12 Months
This measures upper limb impairment and scores from 0 to 66, the higher the score, the less the impairment. 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.
Action Research Arm Test (ARAT)
Time frame: 12 months
This measures arm and hand function and ranges from 0 to 57, the higher the score, the better the upper limb function. The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
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 based exercises and standard physical therapy in people with Hemiplegic Gait, run by Superior 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 5 inclusion and 4 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 14 Jun 2024. 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?
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?
Fugl-Meyer Assessment of upper limb (FMA) (time frame: 12 Months). 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 14 Jun 2024.