StrokeNCT06509698
Comparative Effects of Virtual Reality and Frenkel's Exercises in Patients With Stroke.
A study testing virtual reality and Frenkel's exercise in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of Virtual reality and Frenkel's exercises on balance, gait and quality of life in patients with stroke. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- virtual reality and Frenkel's exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2024to 20 Jul 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1- Age 40-65 years. 2. Stroke patients with both genders. 3. Subacute stroke patients will be included. 4. Survivors of ischemic stroke. 5. No prior experience with VR-based rehabilitation. 6. Patients with ≥24 Mini-Mental State Exam score.
Who cannot join
- Patient with serious behavioral problems or mental health.
- Patients with recent lower extremity deep vein thrombosis, quadriplegia, Parkinson's disease, lower limb fractures, or recent myocardial infarction.
- Patients with malignant tumor, or other unstable condition.
- Participants with ENT defect, hearing, majorly affected vision(blindness), cataract, glaucoma, loss of vision.
- Subjects with diagnosed vestibular disease.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Alveena fatima
Lahore, Punjab Province, 54660
alveena fatima, MS.NMPT, 03111231810, alveena.fatima@yahoo.com
Alveena fatima, Ms. NMPT, 03111231810, alveena.fatima@yahoo.com
About this study
Official title: Comparative Effects of Virtual Reality and Frenkel's Exercises on Balance, Gait and Quality of Life in Patients With Stroke.
To compare the effects of Virtual reality and Frenkel's exercises on balance, gait and quality of life in patients with stroke.
Read the detailed description
This randomized Control trial will be conducted at Islam central hospital, Sialkot over a duration of 7 months after approval of synopsis. 36 Participants who meet the inclusion criteria will be further divided into 2 groups. The treatment will be given with the frequency of 3 times per week for 6 weeks. Treatment sessions will be of 30 minutes with short resting intervals. Data will be collected using various assessment tools including, berg balance scale, time-up and stroke-specific quality of life. Pre-intervention assessment will be conducted before starting the treatment protocol and post assessment after 6 weeks of treatment. The data will be analyzed using SPSS version 28 for Windows software. Statistical significance will be set at p = 0.05. Normality of data will be assessed through Kolmogorov Smirnov test. Difference between pre-treatment and post-treatment readings will be calculated using Paired sample t-test for parametric data. For non-parametric data Wilcoxon test will be used. Independent sample t-test will be used for parametric data and Mann Whitney test will be used for non-parametric data.
- Conditions
- Stroke
- Being tested
- virtual reality, Frenkel's exercise
- Keywords
- Balance, Berg balance scale, Frenkel's exercises, gait, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
STEP I: For the warm-up, the examiner will perform passive stretching exercises to maintain the range of motion. STEP II: The patient will receive the game instructions by the examiner. STEP III: The patient will play the Adventure games and Sport games including tennis, boxing and kicking. virtual reality (20 minutes) using Nintendo Wii®, Wii Fit game will be used to stimulate and reinforce the improvement of balance and gait and enhance the quality of life.(30) Balance game: Soccer Heading, Penguin Slides, Balance Bubble, Torso Twists, and Single Leg Stance. Motor function: Boxing, Kicking, Tennis and Bowling Aerobic Games: 2-P run, advanced step, Title city and Basic Run. Step IV: (cool-down): Same as step one.
Frenkel's exerciseOther
Frenkel's activities, which included learning how to turn around, sit down, and get up using a variety of commonplace objects like chairs, beds, or traces drawn on the floor, as well as learning how to walk with upper limb coordination. This is a typical workout regimen used in testing and rehabilitation centers. Patients engaged in the following activities, each activity time is 1.5 minutes
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | Virtual reality used for balance, gait and quality of life the treatment will be given with the frequency of 3 times per week for 6 weeks. Warmup period, Instruct the patient/participants, Gaming time (20 minutes), cool down period (5 minutes).
Treatment sessions will be of 30 minutes with short resting intervals. Receives: Other: virtual reality |
| Frenkel's exercise | Active comparator | Frenkel's exercise used for balance, gait and quality of life Frenkel's exercise, the treatment will be given with the frequency of 3 times per week for 6 weeks.
Warmup period (5 minutes), frenkel's exercise (20 minutes), cool down period (5 minutes).
Treatment sessions will be of 30 minutes with short resting intervals. Receives: Other: Frenkel's exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
berg balance scale
The BBS is an instrument that assesses functional balance performance in older adults using 14 tasks: sitting to standing, standing unsupported, sitting unsupported, standing to sitting, transfers, standing with eyes closed, standing with feet together, reaching forward with outstretched arm, retrieving object from floor, turning to look behind, turning 360 degrees, placing the foot alternately on a step, standing with 1 foot in front, and standing on 1 foot.18 The maximum score is 56 points, representing normal balance. Each item is scored from 0 (unable to perform) to 4 (normal performance)
Measured: 6-weeks
time up and go
A straightforward performance test called the Timed-Up-and-Go (TUG) is frequently used to evaluate stroke patients' functional mobility and may be able to reveal some information on turning movement. The patient was really instructed to get up from a seated posture, walk three metres, turn around 180 degrees, walk three metres back, turn around 180 degrees, and then sit down once again. It is a viable tool to monitor walkable stroke patients because it is an easy-to-administer, quick test with good intra- and inter-rater reliability, strong convergent validity, and sensitivity to modest changes.4. The amount of time the patient needs to do the task in total determines their score. In fact, the TUG integrates several mobility functions, and its various subcomponents include intricate tasks.
Measured: 6-weeks
stroke specific quality of life
A disease-specific patient-reported outcome measure called the SSQOL was created to evaluate the quality of life for stroke survivors. The 48 items are categorized into 12 domains: job, language, mobility, thinking, personality, mood, family roles, social roles, energy, self-care, vision, and upper extremity function. Each domain has three to six items. Likert scale answers are used for the items, with the least impacted item receiving a score of one and the unaffected item receiving a score of five. The questionnaire has a maximum total score of 245 and a minimum score of 49. A quality of life score of 60% of the maximum value indicates poor life.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start20 Feb 2024
- Primary completion12 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alveena Fatima, Ms.NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509698
- Sponsor's protocol ID
- REC/RCR&AHS/23/0284 Aqsa
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng X, Wu X, Liu Z, Wang J, Wang K, Yin J, Wang X. The Influences of Tai Chi on Balance Function and Exercise Capacity among Stroke Patients: A Meta-Analysis. Evid Based Complement Alternat Med. 2021 Feb 24;2021:6636847. doi: 10.1155/2021/6636847. eCollection 2021.
PubMed 33708256Beckwee D, Lefeber N, Bautmans I, Cuypers L, De Keersmaecker E, De Raedt S, Kerckhofs E, Nagels G, Njemini R, Perkisas S, Scheys E, Swinnen E. Muscle changes after stroke and their impact on recovery: time for a paradigm shift? Review and commentary. Top Stroke Rehabil. 2021 Mar;28(2):104-111. doi: 10.1080/10749357.2020.1783916. Epub 2020 Jun 26.
PubMed 32588773Duan J, Gao S, Tu S, Lenahan C, Shao A, Sheng J. Pathophysiology and Therapeutic Potential of NADPH Oxidases in Ischemic Stroke-Induced Oxidative Stress. Oxid Med Cell Longev. 2021 Mar 9;2021:6631805. doi: 10.1155/2021/6631805. eCollection 2021.
PubMed 33777315Hsu CC, Fu TC, Huang SC, Chen CP, Wang JS. Increased serum brain-derived neurotrophic factor with high-intensity interval training in stroke patients: A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jul;64(4):101385. doi: 10.1016/j.rehab.2020.03.010. Epub 2020 May 11.
PubMed 32344098Feske SK. Ischemic Stroke. Am J Med. 2021 Dec;134(12):1457-1464. doi: 10.1016/j.amjmed.2021.07.027. Epub 2021 Aug 27.
PubMed 34454905Uwishema O, Berjaoui C, Correia IFS, Anis H, Karabulut E, Essayli D, Mhanna M, Oluyemisi A. Current management of acute ischemic stroke in Africa: A review of the literature. Eur J Neurol. 2022 Nov;29(11):3460-3465. doi: 10.1111/ene.15495. Epub 2022 Jul 26.
PubMed 35837810Ullah I, Arsh A, Zahir A, Jan S. Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study. Pak J Med Sci. 2020 Nov-Dec;36(7):1613-1617. doi: 10.12669/pjms.36.7.2351.
PubMed 33235584Lau LH, Lew J, Borschmann K, Thijs V, Ekinci EI. Prevalence of diabetes and its effects on stroke outcomes: A meta-analysis and literature review. J Diabetes Investig. 2019 May;10(3):780-792. doi: 10.1111/jdi.12932. Epub 2018 Oct 13.
PubMed 30220102Logallo N, Novotny V, Assmus J, Kvistad CE, Alteheld L, Ronning OM, Thommessen B, Amthor KF, Ihle-Hansen H, Kurz M, Tobro H, Kaur K, Stankiewicz M, Carlsson M, Morsund A, Idicula T, Aamodt AH, Lund C, Naess H, Waje-Andreassen U, Thomassen L. Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial. Lancet Neurol. 2017 Oct;16(10):781-788. doi: 10.1016/S1474-4422(17)30253-3. Epub 2017 Aug 2.
PubMed 28780236
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Virtual Reality and Frenkel's Exercises on Balance, Gait and Quality of Life in Patients With Stroke.
- ClinicalTrials.gov ID
- NCT06509698
- Acronym / sponsor ID
- REC/RCR&AHS/23/0284 Aqsa
- Conditions
- Stroke
- Keywords
- Balance, Berg balance scale, Frenkel's exercises, gait, stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 12 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 19 Jul 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.
To compare the effects of Virtual reality and Frenkel's exercises on balance, gait and quality of life in patients with stroke.
Detailed description
This randomized Control trial will be conducted at Islam central hospital, Sialkot over a duration of 7 months after approval of synopsis. 36 Participants who meet the inclusion criteria will be further divided into 2 groups. The treatment will be given with the frequency of 3 times per week for 6 weeks. Treatment sessions will be of 30 minutes with short resting intervals. Data will be collected using various assessment tools including, berg balance scale, time-up and stroke-specific quality of life. Pre-intervention assessment will be conducted before starting the treatment protocol and post assessment after 6 weeks of treatment. The data will be analyzed using SPSS version 28 for Windows software. Statistical significance will be set at p = 0.05. Normality of data will be assessed through Kolmogorov Smirnov test. Difference between pre-treatment and post-treatment readings will be calculated using Paired sample t-test for parametric data. For non-parametric data Wilcoxon test will be used. Independent sample t-test will be used for parametric data and Mann Whitney test will be used for non-parametric data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Other: virtual realityVirtual reality used for balance, gait and quality of life the treatment will be given with the frequency of 3 times per week for 6 weeks. Warmup period, Instruct the patient/participants, Gaming time (20 minutes), cool down period (5 minutes). Treatment sessions will be of 30 minutes with short resting intervals. |
| Frenkel's exercise | Active comparator | Other: Frenkel's exerciseFrenkel's exercise used for balance, gait and quality of life Frenkel's exercise, the treatment will be given with the frequency of 3 times per week for 6 weeks. Warmup period (5 minutes), frenkel's exercise (20 minutes), cool down period (5 minutes). Treatment sessions will be of 30 minutes with short resting intervals. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1- Age 40-65 years. 2. Stroke patients with both genders. 3. Subacute stroke patients will be included. 4. Survivors of ischemic stroke. 5. No prior experience with VR-based rehabilitation. 6. Patients with ≥24 Mini-Mental State Exam score.
Key exclusion criteria (5 listed)
- Patient with serious behavioral problems or mental health.
- Patients with recent lower extremity deep vein thrombosis, quadriplegia, Parkinson's disease, lower limb fractures, or recent myocardial infarction.
- Patients with malignant tumor, or other unstable condition.
- Participants with ENT defect, hearing, majorly affected vision(blindness), cataract, glaucoma, loss of vision.
- Subjects with diagnosed vestibular disease.
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 realitySTEP I: For the warm-up, the examiner will perform passive stretching exercises to maintain the range of motion. STEP II: The patient will receive the game instructions by the examiner. STEP III: The patient will play the Adventure games and Sport games including tennis, boxing and kicking. virtual reality (20 minutes) using Nintendo Wii®, Wii Fit game will be used to stimulate and reinforce the improvement of balance and gait and enhance the quality of life.(30) Balance game: Soccer Heading, Penguin Slides, Balance Bubble, Torso Twists, and Single Leg Stance. Motor function: Boxing, Kicking, Tennis and Bowling Aerobic Games: 2-P run, advanced step, Title city and Basic Run. Step IV: (cool-down): Same as step one. | Other | virtual reality |
| Frenkel's exerciseFrenkel's activities, which included learning how to turn around, sit down, and get up using a variety of commonplace objects like chairs, beds, or traces drawn on the floor, as well as learning how to walk with upper limb coordination. This is a typical workout regimen used in testing and rehabilitation centers. Patients engaged in the following activities, each activity time is 1.5 minutes | Other | Frenkel's exercise |
Primary outcome
berg balance scale
Time frame: 6-weeks
The BBS is an instrument that assesses functional balance performance in older adults using 14 tasks: sitting to standing, standing unsupported, sitting unsupported, standing to sitting, transfers, standing with eyes closed, standing with feet together, reaching forward with outstretched arm, retrieving object from floor, turning to look behind, turning 360 degrees, placing the foot alternately on a step, standing with 1 foot in front, and standing on 1 foot.18 The maximum score is 56 points, representing normal balance. Each item is scored from 0 (unable to perform) to 4 (normal performance)
time up and go
Time frame: 6-weeks
A straightforward performance test called the Timed-Up-and-Go (TUG) is frequently used to evaluate stroke patients' functional mobility and may be able to reveal some information on turning movement. The patient was really instructed to get up from a seated posture, walk three metres, turn around 180 degrees, walk three metres back, turn around 180 degrees, and then sit down once again. It is a viable tool to monitor walkable stroke patients because it is an easy-to-administer, quick test with good intra- and inter-rater reliability, strong convergent validity, and sensitivity to modest changes.4. The amount of time the patient needs to do the task in total determines their score. In fact, the TUG integrates several mobility functions, and its various subcomponents include intricate tasks.
stroke specific quality of life
Time frame: 6-weeks
A disease-specific patient-reported outcome measure called the SSQOL was created to evaluate the quality of life for stroke survivors. The 48 items are categorized into 12 domains: job, language, mobility, thinking, personality, mood, family roles, social roles, energy, self-care, vision, and upper extremity function. Each domain has three to six items. Likert scale answers are used for the items, with the least impacted item receiving a score of one and the unaffected item receiving a score of five. The questionnaire has a maximum total score of 245 and a minimum score of 49. A quality of life score of 60% of the maximum value indicates poor life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 33708256Zheng X, Wu X, Liu Z, Wang J, Wang K, Yin J, Wang X. The Influences of Tai Chi on Balance Function and Exercise Capacity among Stroke Patients: A Meta-Analysis. Evid Based Complement Alternat Med. 2021 Feb 24;2021:6636847. doi: 10.1155/2021/6636847. eCollection 2021.
- Background: PubMed 32588773Beckwee D, Lefeber N, Bautmans I, Cuypers L, De Keersmaecker E, De Raedt S, Kerckhofs E, Nagels G, Njemini R, Perkisas S, Scheys E, Swinnen E. Muscle changes after stroke and their impact on recovery: time for a paradigm shift? Review and commentary. Top Stroke Rehabil. 2021 Mar;28(2):104-111. doi: 10.1080/10749357.2020.1783916. Epub 2020 Jun 26.
- Background: PubMed 33777315Duan J, Gao S, Tu S, Lenahan C, Shao A, Sheng J. Pathophysiology and Therapeutic Potential of NADPH Oxidases in Ischemic Stroke-Induced Oxidative Stress. Oxid Med Cell Longev. 2021 Mar 9;2021:6631805. doi: 10.1155/2021/6631805. eCollection 2021.
- Background: PubMed 32344098Hsu CC, Fu TC, Huang SC, Chen CP, Wang JS. Increased serum brain-derived neurotrophic factor with high-intensity interval training in stroke patients: A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jul;64(4):101385. doi: 10.1016/j.rehab.2020.03.010. Epub 2020 May 11.
- Background: PubMed 34454905Feske SK. Ischemic Stroke. Am J Med. 2021 Dec;134(12):1457-1464. doi: 10.1016/j.amjmed.2021.07.027. Epub 2021 Aug 27.
- Background: PubMed 35837810Uwishema O, Berjaoui C, Correia IFS, Anis H, Karabulut E, Essayli D, Mhanna M, Oluyemisi A. Current management of acute ischemic stroke in Africa: A review of the literature. Eur J Neurol. 2022 Nov;29(11):3460-3465. doi: 10.1111/ene.15495. Epub 2022 Jul 26.
- Background: PubMed 33235584Ullah I, Arsh A, Zahir A, Jan S. Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study. Pak J Med Sci. 2020 Nov-Dec;36(7):1613-1617. doi: 10.12669/pjms.36.7.2351.
- Background: PubMed 30220102Lau LH, Lew J, Borschmann K, Thijs V, Ekinci EI. Prevalence of diabetes and its effects on stroke outcomes: A meta-analysis and literature review. J Diabetes Investig. 2019 May;10(3):780-792. doi: 10.1111/jdi.12932. Epub 2018 Oct 13.
- Background: PubMed 28780236Logallo N, Novotny V, Assmus J, Kvistad CE, Alteheld L, Ronning OM, Thommessen B, Amthor KF, Ihle-Hansen H, Kurz M, Tobro H, Kaur K, Stankiewicz M, Carlsson M, Morsund A, Idicula T, Aamodt AH, Lund C, Naess H, Waje-Andreassen U, Thomassen L. Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial. Lancet Neurol. 2017 Oct;16(10):781-788. doi: 10.1016/S1474-4422(17)30253-3. Epub 2017 Aug 2.
- 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.
Alveena Fatima, Ms.NMPT 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 and Frenkel's exercise 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 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 19 Jul 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?
Contact Alveena Fatima, Ms.NMPT (03111231810, alveena.fatima@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
berg balance scale (time frame: 6-weeks). The study lists 3 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 NCT06509698, which also lists 9 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 19 Jul 2024.