Otago Exercise Program Combined With Action Observation Training in Stroke Patients

NCT ID: NCT06927323

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-10-30

Brief Summary

Stroke is one of the main causes of adult disability worldwide and global health problem. Due to ongoing neurological sequelae post stroke patients have a two-fold higher risk of falling than other people with same age or gender. As the stroke patients, balance is impaired and can lead to complications such as fall. Promising interventions that could be beneficial to improve the aspects of gait and balance include Otago exercises and Action observation training. The objective of this study is to determine the effects of Otago exercise combined with Action observation (AO) training on the balance, gait and functional activities in post stroke patients.

A double-blinded randomized control trial will be conducted at Rehabilitation centers, outpatient clinics, and Hospitals for ten months. The sample size will consist of 60 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. Participants will be randomly assigned into two groups: 30 to action observation (AO) training plus Otago exercise group (n= 30) and 30 to Otago exercise group (n= 30). The AO plus Otago and Otago groups will be performed 35 to 40 minutes of strength training and balance exercises from the Otago Exercise Program 3 times a week for 12 weeks. Data will be collected through various assessment tools including Berg Balance Scale (for balance), Dynamic gait index (for gait) and Functional Independence Measure (for functional activities). The effects of the interventions will be measured at pre-treatment and post-intervention. Paired t-test will be adopted to find the statistical difference within the groups and independent t-test will be applied to find the statistical difference between the groups. Data analysis will be performed by using SPSS 26 software.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A. Otago Exercise Program

The Otago Exercise Program (Group A) includes specific exercises for strength and balance improvement. These exercises were conducted three times a week. Each training session lasted for 35-40 minutes.

Group Type: EXPERIMENTAL

Otago exercise program

Intervention Type: OTHER

The Otago Exercise Program is composed of strength training and balance training. Strength training consisted of flexion and extension exercises of the knee, ankle, and toe joints, as well as hip opening exercises to strengthen the sides of the pelvis. Balance training consisted of walking backwards, walking in a figure of eight, heel-toe walking, standing on one leg, walking on the heels, walking on the toes, heel-toe walking backwards, standing up from a sitting position, and walking up stairs. Otago exercise program will be performed with action observation train will be instructed to watch a video on a 22-inch screen positioned 1 meter away from them, while comfortably seated in a chair with armrests. They are not allowed to follow along or engage in any movement while watching the video.

B. Action Observation Training combined with Otago exercise program

Participants will be instructed to watch a video on a 22-inch screen positioned 1 meter away from them, while comfortably seated in a chair with armrests. They are not allowed to follow along or engage in any movement while watching the video. The duration of the video viewing will be 17 minutes (1 minute for each video), followed by a 35-minutes of exercise (2 minutes maximum per session).

Group Type: EXPERIMENTAL

Otago exercise program

Intervention Type: OTHER

The Otago Exercise Program is composed of strength training and balance training. Strength training consisted of flexion and extension exercises of the knee, ankle, and toe joints, as well as hip opening exercises to strengthen the sides of the pelvis. Balance training consisted of walking backwards, walking in a figure of eight, heel-toe walking, standing on one leg, walking on the heels, walking on the toes, heel-toe walking backwards, standing up from a sitting position, and walking up stairs. Otago exercise program will be performed with action observation train will be instructed to watch a video on a 22-inch screen positioned 1 meter away from them, while comfortably seated in a chair with armrests. They are not allowed to follow along or engage in any movement while watching the video.

Interventions

Otago exercise program

The Otago Exercise Program is composed of strength training and balance training. Strength training consisted of flexion and extension exercises of the knee, ankle, and toe joints, as well as hip opening exercises to strengthen the sides of the pelvis. Balance training consisted of walking backwards, walking in a figure of eight, heel-toe walking, standing on one leg, walking on the heels, walking on the toes, heel-toe walking backwards, standing up from a sitting position, and walking up stairs. Otago exercise program will be performed with action observation train will be instructed to watch a video on a 22-inch screen positioned 1 meter away from them, while comfortably seated in a chair with armrests. They are not allowed to follow along or engage in any movement while watching the video.

Intervention Type: OTHER

Other Intervention Names

Action Observation Training combined with Otago exercise program

Eligibility Criteria

Inclusion Criteria

Participants fulfilling given criteria will be included in this study

• Both male and female participants will be included
• The age limit for the participants will be 40-65 years
• Sub-acute and chronic ischemic stroke up to 2 years.
• Participants with BBS score between 35-40.
• Participants having Montreal Cognitive Assessment (MoCA) score greater than 24 (out of 30).
• Participants can walk with or without assistance.

Exclusion Criteria

Participants having given criteria will be excluded from this study

• Participants with other neurological diseases.
• Participants who will not be able to understand the informed consent form.
• Participants already involved in an exercise program for fall prevention.
• Participants have no visual field defect, no abnormality in the vestibular organs, no orthopedic disease, and an unrestricted range of motion.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, Phd

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Central Contacts

Aruba Saeed, Phd

Role: CONTACT

arubasaeedpt@gmail.com

03344399403

Other Identifiers

REC/0243 Rimsha Ashfaq

Identifier Type: -

Identifier Source: org_study_id