Stroke, AcuteNCT04797598
Effects of Virtual Reality and Cyclic Training on Balance
A study testing Virtual reality group and Cyclic training group in people with Stroke, Acute, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is the third leading cause of functional disability and death in the world. It leads to many problems that affect gait, upper extremity function and balance. In stroke patients balance dysfunction leads to impaired postural control and walking. Because of poor balance fall rate increases in stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Virtual reality group and Cyclic training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Jan 2021to 1 Apr 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sub-acute stroke
- Able to stand for 5 minutes
- The score of mini mental state examination (MMSE) > 19
- Male and Females (both genders)
- Verbal instructions can follow
Who cannot join
- Visual and auditory problem unable to hear and see feedback from the video game and problem of vestibular system
- Spasticity of lower limb
- Any other medical condition that could affect movement and balance
- Use of pacemaker, apraxia, epilepsy
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Virtual Reality and Cyclic Training on Balance in Sub-acute Stroke
Stroke is the third leading cause of functional disability and death in the world. It leads to many problems that affect gait, upper extremity function and balance. In stroke patients balance dysfunction leads to impaired postural control and walking. Because of poor balance fall rate increases in stroke patients. Balance is an important predictor of outcome in stroke rehabilitation. After stroke difficulties in balance control may be caused by multiple factors such as muscle weakness, impaired proprioception, and asymmetry in weight wearing, spasticity and impaired motor control. Different means are used to treat stroke, some conventional treatments along with new adjunct therapies are usual practice for the rehabilitation of the stroke.
Virtual Reality is choice of adjunct therapy now a days and can be used in different ways for the rehabilitation. Virtual Reality or active video gaming proved their role as vital part of the treatment program in pediatric rehabilitation as well as adult rehabilitation program. These programs help the patient to achieve goals for functional and activities of daily living skills.
Read the detailed description
This study will be a randomized control trial, used to compare the effectiveness of virtual reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique. Assessment will be done by using berg balance scale (BBS) and time up and go test. Subjects in one group will be treated with Virtual reality and Conventional therapy and in other group Cyclic training and Conventional therapy.
- Conditions
- Stroke, Acute
- Being tested
- Virtual reality group, Cyclic training group
- Keywords
- Stroke, Virtual Reality, Cyclic Training, Active Video gaming
- 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 groupOther
This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment
Cyclic training groupOther
This will receive cyclic training session. both group will receive conventional physical therapy as base line treatment
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality group | Active comparator | In this group patients will be treated with virtual reality . This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24. The virtual reality group will receive 30 minutes virtual reality training and 30 minutes conventional treatment. Receives: Other: Virtual reality group |
| Cyclic training group | Active comparator | In this group patients will be treated with cyclic training . This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24. The cyclic training group will receive 30 minutes cyclic training and 30 minutes conventional treatment Receives: Other: Cyclic training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance scale
this tool is used for assessing change from baseline .14 item scale designed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.it is a 14 item scale list with each item consisting of a five point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function. BBS have high validity and reliability of 0.98 41 -56= low fall risk 21-40 = medium fall risk 0-20 = high risk
Measured: 12 weeks
Time up and Go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Interpretation: ≤ 10 seconds = normal. ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid. ≤ 30 seconds = problems, cannot go outside alone, requires gait aid. * A score of ≥ 14 seconds has been shown to indicate high risk of falls.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start21 Jan 2021
- Primary completion15 Mar 2021
- Study completion1 Apr 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 Stroke, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Its a randomized control trial, used to compare the effects of virtual reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Asif A Javed, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797598
- Sponsor's protocol ID
- REC/LHR/20/2054 Qandil Akram
- Status last verified
- May 2021
- First submitted
- 10 Mar 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang S, Hwang WH, Tsai YC, Liu FK, Hsieh LF, Chern JS. Improving balance skills in patients who had stroke through virtual reality treadmill training. Am J Phys Med Rehabil. 2011 Dec;90(12):969-78. doi: 10.1097/PHM.0b013e3182389fae.
PubMed 22019971
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality and Cyclic Training on Balance in Sub-acute Stroke
- ClinicalTrials.gov ID
- NCT04797598
- Acronym / sponsor ID
- REC/LHR/20/2054 Qandil Akram
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Virtual Reality, Cyclic Training, Active Video gaming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 15 Mar 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.
Stroke is the third leading cause of functional disability and death in the world. It leads to many problems that affect gait, upper extremity function and balance. In stroke patients balance dysfunction leads to impaired postural control and walking. Because of poor balance fall rate increases in stroke patients. Balance is an important predictor of outcome in stroke rehabilitation. After stroke difficulties in balance control may be caused by multiple factors such as muscle weakness, impaired proprioception, and asymmetry in weight wearing, spasticity and impaired motor control. Different means are used to treat stroke, some conventional treatments along with new adjunct therapies are usual practice for the rehabilitation of the stroke.
Virtual Reality is choice of adjunct therapy now a days and can be used in different ways for the rehabilitation. Virtual Reality or active video gaming proved their role as vital part of the treatment program in pediatric rehabilitation as well as adult rehabilitation program. These programs help the patient to achieve goals for functional and activities of daily living skills.
Detailed description
This study will be a randomized control trial, used to compare the effectiveness of virtual reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique. Assessment will be done by using berg balance scale (BBS) and time up and go test. Subjects in one group will be treated with Virtual reality and Conventional therapy and in other group Cyclic training and Conventional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Its a randomized control trial, used to compare the effects of virtual reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Active comparator | Other: Virtual reality groupIn this group patients will be treated with virtual reality . This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24. The virtual reality group will receive 30 minutes virtual reality training and 30 minutes conventional treatment. |
| Cyclic training group | Active comparator | Other: Cyclic training groupIn this group patients will be treated with cyclic training . This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24. The cyclic training group will receive 30 minutes cyclic training and 30 minutes conventional treatment |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sub-acute stroke
- Able to stand for 5 minutes
- The score of mini mental state examination (MMSE) > 19
- Male and Females (both genders)
- Verbal instructions can follow
Key exclusion criteria (5 listed)
- Visual and auditory problem unable to hear and see feedback from the video game and problem of vestibular system
- Spasticity of lower limb
- Any other medical condition that could affect movement and balance
- Use of pacemaker, apraxia, epilepsy
- Psychiatric disorders
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 groupThis will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment | Other | Virtual Reality group |
| Cyclic training groupThis will receive cyclic training session. both group will receive conventional physical therapy as base line treatment | Other | Cyclic training group |
Primary outcome
Berg Balance scale
Time frame: 12 weeks
this tool is used for assessing change from baseline .14 item scale designed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.it is a 14 item scale list with each item consisting of a five point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function. BBS have high validity and reliability of 0.98 41 -56= low fall risk 21-40 = medium fall risk 0-20 = high risk
Time up and Go
Time frame: 12 weeks
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. Interpretation: ≤ 10 seconds = normal. ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid. ≤ 30 seconds = problems, cannot go outside alone, requires gait aid. * A score of ≥ 14 seconds has been shown to indicate high risk of falls.
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 11 May 2021.
- Background: PubMed 22019971Yang S, Hwang WH, Tsai YC, Liu FK, Hsieh LF, Chern JS. Improving balance skills in patients who had stroke through virtual reality treadmill training. Am J Phys Med Rehabil. 2011 Dec;90(12):969-78. doi: 10.1097/PHM.0b013e3182389fae.
- 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.
Muhammad Asif A Javed, MS principal investigator
Riphah International University
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 group and Cyclic training group in people with Stroke, Acute, 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 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: finished, as of the sponsor's last update on 11 May 2021. 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?
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?
Berg Balance scale (time frame: 12 weeks). 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 NCT04797598, 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 11 May 2021.