NCT07063368

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 3, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

StrokeFall RiskOtago exercisesBalanceSystematic desensitizationBasophobia

Outcome Measures

Primary Outcomes (3)

  • 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.

    8 weeks

  • 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).

    8 weeks

  • 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.

    8 weeks

Secondary Outcomes (2)

  • Timed Up and Go test

    8 weeks

  • Functional Reach Test

    8 weeks

Study Arms (3)

Otago Exercises and systematic desensitization with routine physical therapy

EXPERIMENTAL

Group 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.

Other: Otago exercises and systematic desensitization with routine physical therapy

Otago Exercises and Routine Physical Therapy

EXPERIMENTAL

Group 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.

Other: Otago Exercises and Routine physical Therapy

Systematic desensitization and Routine physical therapy

EXPERIMENTAL

Group 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.

Other: Systematic desensitization and routine physical therapy

Interventions

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 systematic desensitization with routine physical therapy

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.

Otago Exercises and Routine Physical Therapy

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.

Systematic desensitization and Routine physical therapy

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female patients
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allama Iqbal Memorial Teaching Hospiatl

Sialkot, Punjab Province, 05134, Pakistan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 38503146BACKGROUND
  • 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.

    PMID: 38607735BACKGROUND
  • 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.

    PMID: 39685016BACKGROUND
  • 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.

    PMID: 37390692BACKGROUND
  • 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.

    PMID: 34358276BACKGROUND
  • 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.

    PMID: 36339194BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hira Jabeen, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sana Muzammil, MS-NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

June 26, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations