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StrokeNCT07063368

Effects of Otago Exercises and Systematic Desensitization on Balance,Fall Risk and Basophobia Among Post Stroke Patients

A study testing Otago exercises and systematic desensitization with routine physical therapy, Otago Exercises and Routine physical Therapy and Systematic desensitization and routine physical therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study is to determine the combined effects of Otago exercises and systematic desensitization on balance, fall risk, and basophobia among post-stroke older adults. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Stroke
What is being tested?
Otago exercises and systematic desensitization with routine physical therapy, Otago Exercises and Routine physical Therapy and Systematic desensitization and routine physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 sitePakistan
Study dates
26 Jun 2025to Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Both male and female patients
  • 40 to 70 Years of age
  • sub-acute ischemic stroke
  • Ability to walk with or without a caregiver
  • No cognitive dysfunction that would hinder understanding of the instructions
  • MoCA score between 18-24

Who cannot join

  • Patients previous participation in studies similar to the present study.
  • Participants who have other medical conditions such as severe arthritis or joint injuries.
  • Participants who have a history of significant neurological or psychiatric disorders
  • Participants who have severe visual or hearing impairments
  • Participants who are currently participating in another clinical trial or research study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sana Muzammil, MS-NMPT contact

+923327143610

sanamuzammilmughal33@gmail.com

Pakistan1 site, 1 recruiting
  • Allama Iqbal Memorial Teaching Hospiatl

    Sialkot, Punjab Province, 05134

    Hira Jabeen, PhD, +923234116506, hira.jabeen@riphah.edu.pk

    Sana Muzammil, MSNMPT

    Recruiting

Other trials in Pakistan

About this study

Official title: Combined Effects of Otago Exercises and Systematic Desensitization on Balance,Fall Risk and Basophobia Among Post Stroke Older Adults

The aim of the study is to determine the combined effects of Otago exercises and systematic desensitization on balance, fall risk, and basophobia among post-stroke older adults.

Read the detailed description

Stroke survivors often face challenges such as impaired balance, heightened fall risk, and basophobia (fear of falling), which significantly impact their daily lives and rehabilitation outcomes. Stroke patients have a two-fold higher risk of falling than other patients of the same age or gender.In particular, 30% to 50% of the elderly those over 65 years old, experience falls every year. The Otago Exercise Program, recognized for its efficacy in improving balance and reducing falls among older adults, and systematic desensitization, a psychological intervention aimed at reducing fear and anxiety related to falling, offer complementary approaches to address these challenges. This study aims to investigate the combined effects of Otago exercises and systematic desensitization on balance, fall risk, and basophobia among post-stroke older adults.

This randomized controlled trial will be conducted at Allama Iqbal Memorial Teaching Hospital Sialkot over six months. The sample size will consist of 51 participants. Participants who meet the inclusion criteria will be taken through a non-probability convenience sampling technique, which will further be randomized through flip coin method. 17 Participants will be assigned to group A (otago exercise, systematic desensitization and routine physical therapy, 17 participants to group B( Otago Exercises and Routine Physical therapy ) and 17 participants were included in group C ( Systematic desensitization and Routine physical therapy only ).

Data will be collected using various assessment tools, including the Berg Balance Scale to assess balance , Timed up and go test for dynamic balance, Functional Reach Test for static balance, Fall Risk assessment scale to assess risk of fall, Fall Efficacy Scale International for risk of fall, and Fear of fall avoidance behavior questionnaire for basophobia. Pre-intervention assessments will be conducted for all three groups. The effects of the interventions will be measured at pre-treatment, 4th week, and post-intervention. Data analysis will be performed by using SPSS 26 software.

Conditions
Stroke
Being tested
Otago exercises and systematic desensitization with routine physical therapy, Otago Exercises and Routine physical Therapy, Systematic desensitization and routine physical therapy
Keywords
Stroke, Fall Risk, Otago exercises, Balance, Systematic desensitization, Basophobia
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Otago exercises and systematic desensitization with routine physical therapyOther

    Warm-up (5 minutes) Marching in place (assisted), arm swings, side steps Otago Balance Exercises (7 minutes) Knee bends (with support), heel-to-toe stand (with support), side hip abduction (with support) Otago Strength Exercises (8 minutes) Ankle dorsiflexion, seated knee extensions, seated marching Routine Physical Therapy - Strength and Mobility Exercises (15 minutes) Assisted squats or sit-to-stand exercises, standing calf raises (with support), seated bicep curls, seated shoulder press Routine Physical Therapy - Flexibility and Stretching (5 minutes) Hamstring, quadriceps, shoulder, and neck stretches Relaxation Training (7 minutes) Review goals, PMR, deep breathing exercises Gradual Exposure and Visualization (10 minutes) Visualization of safe environments, standing up, walking on flat surfaces, and mildly fear-inducing situations (with assistance) Discussion and Feedback (3 minutes) Share experiences, provide feedback, assign homework

  • Otago Exercises and Routine physical TherapyOther

    Warm-up (10 minutes) Marching in place, arm swings, and side steps. Otago Balance Exercises (10 minutes) Knee bends, heel-to-toe stand, side hip abduction. Otago Strength Exercises (10 minutes) Ankle dorsiflexion, seated knee extensions, seated marching. Routine Physical Therapy - Strength and Mobility Exercises (20 minutes) Assisted squats or sit-to-stand exercises, standing calf raises with support, seated bicep curls, seated shoulder press.

    Routine Physical Therapy - Flexibility and Stretching (10 minutes) Hamstring stretch, quadriceps stretch, shoulder and neck stretches, seated torso twist.

  • Systematic desensitization and routine physical therapyOther

    Warm-up (5 minutes) Marching in place, arm swings, and side steps. Routine Physical Therapy - Strength and Mobility Exercises (20 minutes) Assisted squats or sit-to-stand exercises, standing calf raises with support, seated bicep curls, seated shoulder press.

    Routine Physical Therapy - Flexibility and Stretching (5 minutes) Hamstring stretch, quadriceps stretch, shoulder and neck stretches. Relaxation Training (10 minutes) Review goals and expectations, PMR, deep breathing exercises. Gradual Exposure and Visualization (15 minutes) Visualization of safe environments, standing up, walking on flat surfaces, and mildly fear-inducing situations (with assistance).

    Discussion and Feedback (5 minutes) Share experiences, provide feedback, and assign homework.

Study groups in NCT07063368
Study groupRoleWhat they receive
Otago Exercises and systematic desensitization with routine physical therapyExperimentalGroup A emphasizes a combination of Otago exercises and systematic desensitization alongside routine physical therapy. The session begins with a 5-minute warm-up, followed by 7 minutes of Otago balance exercises and 8 minutes of Otago strength exercises. This is complemented by 15 minutes of routine physical therapy focusing on strength and mobility, 5 minutes of flexibility and stretching, and 7 minutes dedicated to relaxation training. The session concludes with 10 minutes of gradual exposure and visualization exercises, allowing participants to mentally navigate safe environments and mildly fear-inducing situations, followed by a 3-minute discussion and feedback segment.
Receives: Other: Otago exercises and systematic desensitization with routine physical therapy
Otago Exercises and Routine Physical TherapyExperimentalGroup B, centers solely on Otago exercises integrated with routine physical therapy. This group starts with a 10-minute warm-up, followed by 10 minutes of Otago balance exercises and another 10 minutes for Otago strength exercises. The session continues with 20 minutes of routine physical therapy focused on strength and mobility, concluding with 10 minutes dedicated to flexibility and stretching exercises.
Receives: Other: Otago Exercises and Routine physical Therapy
Systematic desensitization and Routine physical therapyExperimentalGroup C combines systematic desensitization with routine physical therapy. The session begins with a 5-minute warm-up, followed by 20 minutes of strength and mobility exercises, and 5 minutes of flexibility and stretching. Participants then engage in 10 minutes of relaxation training, which includes reviewing goals and practicing deep breathing exercises. The session further incorporates 15 minutes of gradual exposure and visualization, allowing participants to confront their fears in a controlled manner, and wraps up with a 5-minute discussion and feedback period.
Receives: Other: Systematic desensitization and routine physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fall Risk Assessment Scale

    It is a 4-item falls-risk screening tool for sub-acute and residential care. The FRAT has three sections: Part 1 - Fall Risks, Part 2 -Risk factor checklist, Part 3 :Action Plan. A score of 0 to 5 indicates a low risk of falling, a score of 6 to 20 a medium risk, and a score 21 to 45 a high risk.

    Measured: 8 weeks

  2. Fall Efficacy Scale International

    The Falls Efficacy Scale International (FES-I) is a measure of fear of falling. It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).

    Measured: 8 weeks

  3. Berg Balance Scale

    The Berg Balance Scale (BBS) is a clinical tool used to assess balance and risk of falling. It consists of 14 simple tasks, such as standing, sitting, and reaching, each scored on a scale of 0 to 4. The total score helps determine the level of balance impairment.

    Measured: 8 weeks

Secondary outcomes (2)
  1. Timed Up and Go test

    The Timed Up and Go (TUG) test is a simple and quick assessment used to evaluate a person's mobility, balance, walking ability, and fall risk. It involves timing an individual as they stand up from a chair, walk three meters, turn around, walk back, and sit down. A time of 12 seconds or more typically indicates a higher risk of falling

    Measured: 8 weeks

  2. Functional Reach Test

    It is a quick, single-task, dynamic test that is used to predicting falls in older adults. This test measures the margin of stability along with the ability to measure balance during a functional task.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start26 Jun 2025
  3. Primary completionOct 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

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
Participant
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07063368
Sponsor's protocol ID
REC/RCR & AHS/24/0254
Status last verified
Jul 2025
First submitted
3 Jul 2025
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peng Y, Wang Y, Zhang L, Zhang Y, Sha L, Dong J, He Y. Virtual reality exergames for improving physical function, cognition and depression among older nursing home residents: A systematic review and meta-analysis. Geriatr Nurs. 2024 May-Jun;57:31-44. doi: 10.1016/j.gerinurse.2024.02.032. Epub 2024 Mar 18.

    PubMed 38503146
  • Wang J, Li Y, Yang GY, Jin K. Age-Related Dysfunction in Balance: A Comprehensive Review of Causes, Consequences, and Interventions. Aging Dis. 2024 Jan 24;16(2):714-737. doi: 10.14336/AD.2024.0124-1.

    PubMed 38607735
  • Zhong YJ, Meng Q, Su CH. Mechanism-Driven Strategies for Reducing Fall Risk in the Elderly: A Multidisciplinary Review of Exercise Interventions. Healthcare (Basel). 2024 Nov 29;12(23):2394. doi: 10.3390/healthcare12232394.

    PubMed 39685016
  • Yi M, Zhang W, Zhang X, Zhou J, Wang Z. The effectiveness of Otago exercise program in older adults with frailty or pre-frailty: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2023 Nov;114:105083. doi: 10.1016/j.archger.2023.105083. Epub 2023 Jun 22.

    PubMed 37390692
  • Chiu HL, Yeh TT, Lo YT, Liang PJ, Lee SC. The effects of the Otago Exercise Programme on actual and perceived balance in older adults: A meta-analysis. PLoS One. 2021 Aug 6;16(8):e0255780. doi: 10.1371/journal.pone.0255780. eCollection 2021.

    PubMed 34358276
  • Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.

    PubMed 36339194

Questions about this trial

What is this clinical trial studying?

A study testing Otago exercises and systematic desensitization with routine physical therapy, Otago Exercises and Routine physical Therapy and Systematic desensitization and routine physical therapy 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 6 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: looking for participants now, as of the sponsor's last update on 14 Jul 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sana Muzammil, MS-NMPT (+923327143610, sanamuzammilmughal33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fall Risk Assessment Scale (time frame: 8 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 NCT07063368, which also lists 6 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 14 Jul 2025.

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