Clinical trial NCT06927323: Otago Exercise Program Combined With Action Observation Training in Stroke Patients
Official title: Effects of Otago Exercise Program Combined With Action Observation Training on Balance, Gait and Functional Activities in Post Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Action observation training, Otago exercises, Stroke, Gait, Balance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Berg Balance Scale (for balance)
timeFrame: 8 weeks
measure: Dynamic Gait Index (for gait)
timeFrame: 8 weeks
measure: Functional Independence Measure (for functional activities)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, Phd
role: PRINCIPAL_INVESTIGATOR
References: