Parkinson DiseaseNCT05325541
Effects of Visual Biofeedback Therapy in Parkinson's Patients
A study testing Visual Biofeedback Therapy and Conventional Balance exercise in people with Parkinson Disease, run by Ziauddin University at 1 site in Pakistan.
Trial summary
Parkinson's disease (PD) affects approximately 6.5 million people around the world and it is ranked as the second most common age-related neurodegenerative disease after Alzheimer disease. Read more about this study
- Who is it for?
- Ages 60 to 79 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Visual Biofeedback Therapy and Conventional Balance exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 15 Aug 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 60 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease of age between 60-79 years.
- Diagnosed PD stage III.
Who cannot join
- Other neurological problems (Multiple sclerosis, amyotrophic lateral sclerosis and myasthenia gravis).
- Migraine.
- Auditory or visual deficits.
- Orthostatic hypotension.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ziauddin University
Karachi, Sindh
Fouzia Hussain, MPhil, 021-36629251 ext. 5, fouziaphysio@gmail.com
About this study
Official title: Effects of Visual Biofeedback Therapy on Balance, Freezing of Gait and Cognition Among Stage III Parkinson's Patients: A Randomized Controlled Trial
Parkinson's disease (PD) affects approximately 6.5 million people around the world and it is ranked as the second most common age-related neurodegenerative disease after Alzheimer disease. US have reported 800,000 PD patients in 2016, the highest number of reported PD patients in the world while UK has the lowest number of PD cases i.e. 100,000. With a rise of 2.3 million cases in 2026, an approximate annual growth rate of 2.52% is predicted globally. According to Pakistan Parkinson's society, approximately 450,000 Pakistanis were affected with PD. The age-specific prevalence of PD in Pakistan was found to be high in 70 to 79 years of age with males being more affected as compared to females. Parkinson's disease is a neurological condition, characterized by tremors, rigidity, and stiffness in the body, along with bradykinesia, walking and balance problems. Poor balance is one of the major and most disabling characteristics among Parkinson patients. Freezing of gait (FOG) and postural instability is one of the major cause of fall and loss of independence among PD patients whereas cognitive dysfunction is one of the common non-motor symptoms affecting 20 to 57% of PD patients. Among recent technological advancements in neurological physical therapy, virtual reality (VR) games have become an area of interest for researchers. Despite advances in the rehabilitation of PD, evidence regarding the effects of visual biofeedback therapy on Parkinson patients is still scarce. Only few studies have studied the effects of visual biofeedback therapy on balance in PD patients, but as per knowledge of the researcher there is no study published on effects of visual biofeedback therapy on FOG and cognition among Parkinson patients in Pakistan. Therefore, the present study is aimed to assess the effects of biofeedback balance training using a balance board on balance, FOG and cognition in patients with Parkinson disease.
Read the detailed description
A total number of 36 patients will be recruited in the study. After the voluntary consent, all the patients will be randomly divided into Group A and B through the envelope method of simple random sampling. In addition, a total of 36 sealed envelopes, comprised of 18 envelopes for each group will be presented to the patients. Each patient will be asked to select one envelope of their choice. Upon selection of the envelope, patients will be allocated to the respective group. Thus, each group will comprise 18 patients respectively. Afterward, pre-assessment will be performed for each patient on all three outcome measures i.e. FRT, FOG-Q, and MoCA. A total of 36 patients will be recruited and assigned into two groups. Group A will receive visual biofeedback balance exercises and Group B will receive Conventional balance exercises. The intervention will be given for 8 consecutive weeks to each group. The training session will be based on a warm-up session for 5 to 10 minutes to each group followed by 30 minutes' session of visual biofeedback therapy for group A and 30 minutes balance exercises for group B and a cool-down period of 5 to 10 minutes excluding intervals of 1-minute rest after 5 minutes of activity. A trial will be terminated, if the patient reported ataxia, vertigo and syncope, feeling of fatigue and difficulty during exercise through fatigue severity scale and subjects unwilling to perform exercise.
- Conditions
- Parkinson Disease
- Being tested
- Visual Biofeedback Therapy, Conventional Balance exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Biofeedback TherapyDevice
Visual Biofeedback intervention will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.
Conventional Balance exerciseBehavioural
Conventional Balance exercises will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arms 1 | Experimental | Game-Based Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks. Receives: Device: Visual Biofeedback Therapy |
| Arms 2 | Placebo comparator | Conventional Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks. Receives: Behavioral: Conventional Balance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function
Measured: Baseline
Balance
Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function
Measured: After 8 weeks
Freezing of Gait (FOG)
Freezing of Gait will be assessed through FOG Questionnaire among stage III PD patients where low values indicates decrease in freezing of gait
Measured: Pre-Treatment
Freezing of Gait (FOG)
Freezing of Gait will be assessed through FOG Questionnaire among stage III PD patients where low values indicates decrease in freezing of gait
Measured: After 8 weeks
Cognitive Function
Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function
Measured: Pre-Treatment
Cognitive Function
Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function
Measured: After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Mar 2022
- Primary completion20 Jul 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Game-Based Rehabilitation: Device: Visual Biofeedback Therapy Session Visual Biofeedback intervention will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks. Placebo Comparator: Conventional Rehabilitation: Conventional Balance exercise Conventional Balance exercises will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fouzia Hussain, MPhil, Principal investigator, Ziauddin University Karachi, Sindh, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325541
- Sponsor's protocol ID
- 4471121FHREH
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aguilar-Navarro SG, Mimenza-Alvarado AJ, Palacios-Garcia AA, Samudio-Cruz A, Gutierrez-Gutierrez LA, Avila-Funes JA. Validity and Reliability of the Spanish Version of the Montreal Cognitive Assessment (MoCA) for the Detection of Cognitive Impairment in Mexico. Rev Colomb Psiquiatr (Engl Ed). 2018 Oct-Dec;47(4):237-243. doi: 10.1016/j.rcp.2017.05.003. Epub 2017 Jul 29. English, Spanish.
PubMed 30286846Feng YS, Yang SD, Tan ZX, Wang MM, Xing Y, Dong F, Zhang F. The benefits and mechanisms of exercise training for Parkinson's disease. Life Sci. 2020 Mar 15;245:117345. doi: 10.1016/j.lfs.2020.117345. Epub 2020 Jan 22.
PubMed 31981631Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.
PubMed 29337023Gupta DK, Fahn S, Tatsuoka C, Kang UJ. Hoehn and Yahr stage 3 and postural stability item in the movement disorder society-unified Parkinson's disease rating scale. Mov Disord. 2018 Jul;33(7):1188-1189. doi: 10.1002/mds.27453. No abstract available.
PubMed 30153396Hulzinga F, Nieuwboer A, Dijkstra BW, Mancini M, Strouwen C, Bloem BR, Ginis P. The New Freezing of Gait Questionnaire: Unsuitable as an Outcome in Clinical Trials? Mov Disord Clin Pract. 2020 Jan 14;7(2):199-205. doi: 10.1002/mdc3.12893. eCollection 2020 Feb.
PubMed 32071940Khan S, Nabi G, Naeem M, Ali L, Silburn PA, Mellick GD. A door-to-door survey to estimate the prevalence of Parkinsonism in Pakistan. Neuropsychiatr Dis Treat. 2016 Jun 21;12:1499-506. doi: 10.2147/NDT.S86329. eCollection 2016.
PubMed 27382292Negrini S, Bissolotti L, Ferraris A, Noro F, Bishop MD, Villafane JH. Nintendo Wii Fit for balance rehabilitation in patients with Parkinson's disease: A comparative study. J Bodyw Mov Ther. 2017 Jan;21(1):117-123. doi: 10.1016/j.jbmt.2016.06.001. Epub 2016 Jun 11.
PubMed 28167167Taimur M, Shah MAA, Ali M, Barry HD, Hussain SZM, Shahzad H, Rizwan A. Frequency of Cognitive Impairment in Patients with Parkinson's Disease. Cureus. 2019 May 23;11(5):e4733. doi: 10.7759/cureus.4733.
PubMed 31355092Yuan RY, Chen SC, Peng CW, Lin YN, Chang YT, Lai CH. Effects of interactive video-game-based exercise on balance in older adults with mild-to-moderate Parkinson's disease. J Neuroeng Rehabil. 2020 Jul 13;17(1):91. doi: 10.1186/s12984-020-00725-y.
PubMed 32660512Santos P, Machado T, Santos L, Ribeiro N, Melo A. Efficacy of the Nintendo Wii combination with Conventional Exercises in the rehabilitation of individuals with Parkinson's disease: A randomized clinical trial. NeuroRehabilitation. 2019;45(2):255-263. doi: 10.3233/NRE-192771.
PubMed 31498138Cabrera-Martos I, Jimenez-Martin AT, Lopez-Lopez L, Rodriguez-Torres J, Ortiz-Rubio A, Valenza MC. Effects of a core stabilization training program on balance ability in persons with Parkinson's disease: a randomized controlled trial. Clin Rehabil. 2020 Jun;34(6):764-772. doi: 10.1177/0269215520918631. Epub 2020 Apr 29.
PubMed 32349543
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Visual Biofeedback Therapy on Balance, Freezing of Gait and Cognition Among Stage III Parkinson's Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05325541
- Acronym / sponsor ID
- 4471121FHREH
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 13 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.
Parkinson's disease (PD) affects approximately 6.5 million people around the world and it is ranked as the second most common age-related neurodegenerative disease after Alzheimer disease. US have reported 800,000 PD patients in 2016, the highest number of reported PD patients in the world while UK has the lowest number of PD cases i.e. 100,000. With a rise of 2.3 million cases in 2026, an approximate annual growth rate of 2.52% is predicted globally. According to Pakistan Parkinson's society, approximately 450,000 Pakistanis were affected with PD. The age-specific prevalence of PD in Pakistan was found to be high in 70 to 79 years of age with males being more affected as compared to females. Parkinson's disease is a neurological condition, characterized by tremors, rigidity, and stiffness in the body, along with bradykinesia, walking and balance problems. Poor balance is one of the major and most disabling characteristics among Parkinson patients. Freezing of gait (FOG) and postural instability is one of the major cause of fall and loss of independence among PD patients whereas cognitive dysfunction is one of the common non-motor symptoms affecting 20 to 57% of PD patients. Among recent technological advancements in neurological physical therapy, virtual reality (VR) games have become an area of interest for researchers. Despite advances in the rehabilitation of PD, evidence regarding the effects of visual biofeedback therapy on Parkinson patients is still scarce. Only few studies have studied the effects of visual biofeedback therapy on balance in PD patients, but as per knowledge of the researcher there is no study published on effects of visual biofeedback therapy on FOG and cognition among Parkinson patients in Pakistan. Therefore, the present study is aimed to assess the effects of biofeedback balance training using a balance board on balance, FOG and cognition in patients with Parkinson disease.
Detailed description
A total number of 36 patients will be recruited in the study. After the voluntary consent, all the patients will be randomly divided into Group A and B through the envelope method of simple random sampling. In addition, a total of 36 sealed envelopes, comprised of 18 envelopes for each group will be presented to the patients. Each patient will be asked to select one envelope of their choice. Upon selection of the envelope, patients will be allocated to the respective group. Thus, each group will comprise 18 patients respectively. Afterward, pre-assessment will be performed for each patient on all three outcome measures i.e. FRT, FOG-Q, and MoCA. A total of 36 patients will be recruited and assigned into two groups. Group A will receive visual biofeedback balance exercises and Group B will receive Conventional balance exercises. The intervention will be given for 8 consecutive weeks to each group. The training session will be based on a warm-up session for 5 to 10 minutes to each group followed by 30 minutes' session of visual biofeedback therapy for group A and 30 minutes balance exercises for group B and a cool-down period of 5 to 10 minutes excluding intervals of 1-minute rest after 5 minutes of activity. A trial will be terminated, if the patient reported ataxia, vertigo and syncope, feeling of fatigue and difficulty during exercise through fatigue severity scale and subjects unwilling to perform exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental: Game-Based Rehabilitation: Device: Visual Biofeedback Therapy Session Visual Biofeedback intervention will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks. Placebo Comparator: Conventional Rehabilitation: Conventional Balance exercise Conventional Balance exercises will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Arms 1 | Experimental | Device: Visual Biofeedback TherapyGame-Based Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks. |
| Arms 2 | Placebo comparator | Behavioral: Conventional Balance exerciseConventional Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson's disease of age between 60-79 years.
- Diagnosed PD stage III.
Key exclusion criteria (4 listed)
- Other neurological problems (Multiple sclerosis, amyotrophic lateral sclerosis and myasthenia gravis).
- Migraine.
- Auditory or visual deficits.
- Orthostatic hypotension.
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 |
|---|---|---|
| Visual Biofeedback TherapyVisual Biofeedback intervention will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks. | Device | Arms 1 |
| Conventional Balance exerciseConventional Balance exercises will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks. | Behavioural | Arms 2 |
Primary outcome
Balance
Time frame: Baseline
Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function
Balance
Time frame: After 8 weeks
Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function
Freezing of Gait (FOG)
Time frame: Pre-Treatment
Freezing of Gait will be assessed through FOG Questionnaire among stage III PD patients where low values indicates decrease in freezing of gait
Freezing of Gait (FOG)
Time frame: After 8 weeks
Freezing of Gait will be assessed through FOG Questionnaire among stage III PD patients where low values indicates decrease in freezing of gait
Cognitive Function
Time frame: Pre-Treatment
Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function
Cognitive Function
Time frame: After 8 weeks
Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: PubMed 30286846Aguilar-Navarro SG, Mimenza-Alvarado AJ, Palacios-Garcia AA, Samudio-Cruz A, Gutierrez-Gutierrez LA, Avila-Funes JA. Validity and Reliability of the Spanish Version of the Montreal Cognitive Assessment (MoCA) for the Detection of Cognitive Impairment in Mexico. Rev Colomb Psiquiatr (Engl Ed). 2018 Oct-Dec;47(4):237-243. doi: 10.1016/j.rcp.2017.05.003. Epub 2017 Jul 29. English, Spanish.
- Background: PubMed 31981631Feng YS, Yang SD, Tan ZX, Wang MM, Xing Y, Dong F, Zhang F. The benefits and mechanisms of exercise training for Parkinson's disease. Life Sci. 2020 Mar 15;245:117345. doi: 10.1016/j.lfs.2020.117345. Epub 2020 Jan 22.
- Background: PubMed 29337023Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.
- Background: PubMed 30153396Gupta DK, Fahn S, Tatsuoka C, Kang UJ. Hoehn and Yahr stage 3 and postural stability item in the movement disorder society-unified Parkinson's disease rating scale. Mov Disord. 2018 Jul;33(7):1188-1189. doi: 10.1002/mds.27453. No abstract available.
- Background: PubMed 32071940Hulzinga F, Nieuwboer A, Dijkstra BW, Mancini M, Strouwen C, Bloem BR, Ginis P. The New Freezing of Gait Questionnaire: Unsuitable as an Outcome in Clinical Trials? Mov Disord Clin Pract. 2020 Jan 14;7(2):199-205. doi: 10.1002/mdc3.12893. eCollection 2020 Feb.
- Background: PubMed 27382292Khan S, Nabi G, Naeem M, Ali L, Silburn PA, Mellick GD. A door-to-door survey to estimate the prevalence of Parkinsonism in Pakistan. Neuropsychiatr Dis Treat. 2016 Jun 21;12:1499-506. doi: 10.2147/NDT.S86329. eCollection 2016.
- Background: PubMed 28167167Negrini S, Bissolotti L, Ferraris A, Noro F, Bishop MD, Villafane JH. Nintendo Wii Fit for balance rehabilitation in patients with Parkinson's disease: A comparative study. J Bodyw Mov Ther. 2017 Jan;21(1):117-123. doi: 10.1016/j.jbmt.2016.06.001. Epub 2016 Jun 11.
- Background: PubMed 31355092Taimur M, Shah MAA, Ali M, Barry HD, Hussain SZM, Shahzad H, Rizwan A. Frequency of Cognitive Impairment in Patients with Parkinson's Disease. Cureus. 2019 May 23;11(5):e4733. doi: 10.7759/cureus.4733.
- Background: PubMed 32660512Yuan RY, Chen SC, Peng CW, Lin YN, Chang YT, Lai CH. Effects of interactive video-game-based exercise on balance in older adults with mild-to-moderate Parkinson's disease. J Neuroeng Rehabil. 2020 Jul 13;17(1):91. doi: 10.1186/s12984-020-00725-y.
- Background: PubMed 31498138Santos P, Machado T, Santos L, Ribeiro N, Melo A. Efficacy of the Nintendo Wii combination with Conventional Exercises in the rehabilitation of individuals with Parkinson's disease: A randomized clinical trial. NeuroRehabilitation. 2019;45(2):255-263. doi: 10.3233/NRE-192771.
- Background: PubMed 32349543Cabrera-Martos I, Jimenez-Martin AT, Lopez-Lopez L, Rodriguez-Torres J, Ortiz-Rubio A, Valenza MC. Effects of a core stabilization training program on balance ability in persons with Parkinson's disease: a randomized controlled trial. Clin Rehabil. 2020 Jun;34(6):764-772. doi: 10.1177/0269215520918631. Epub 2020 Apr 29.
- 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.
Fouzia Hussain, MPhil principal investigator
Ziauddin University Karachi, Sindh, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Biofeedback Therapy and Conventional Balance exercise in people with Parkinson Disease, run by Ziauddin 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 2 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 13 Apr 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. Some participants in this study may receive a placebo. 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 Fouzia Hussain, MPhil (021-36629251 ext. 5, fouziaphysio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Baseline). The study lists 6 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 NCT05325541, which also lists 11 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 13 Apr 2022.