Comparison of Otago Exercises Versus Resistance Training on Functional Performance in Stroke Patients

Sponsor

Shifa Tameer-e-Millat University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06034236

Collaborator

(none)

Enrollment

Location

Arms

2.2

Anticipated Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Otago techniques are well known for addressing balance and strength deficiencies in healthy older population with fall risk. Despite this, there is limited literature about the Otago approaches' effectiveness in stroke patients. To the best of our knowledge, no research has been done in Pakistan to determine the effects of Otago exercises on chronic stroke patients.Otago exercises are easy to learn and create a sense of motivation and pleasurable activity when performed. To determine the effect of Otago exercises in treating poor balance control and reduced strength, the current study has chosen chronic stroke patients as its target population. The results of this study will serve as a manual for physical therapists on how to efficiently incorporate Otago Intervention into their treatment plans for better outcomes.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Resistance training Other: Otago Exercises	N/A

Detailed Description

Stroke is a focal neurological deficit. It causes functional impairments and activity limitation in the body after survival from the sudden attack, which includes disorder in language, movement, cognition and eating difficulties. Motor deficits are most common in stroke, it is directly related to reduction in strength, balance, gait speed and quality of life. Emotional and physical changes also occur, these all factors combine to affect everyday activities. By improving functional performance and strength in lower extremity, it will improve gait speed and balance control.

Around the world among the major causes of death, stroke stands on the third number. Task specific progressive resistance training uses the preserved energy in muscles to increase strength and balance. Training has to be carried out at a specific intensity and increase progressively which will lead to improvement in fitness and strength level. Progressive resistance training is an umbrella that consists of multiple different and unique set of interventions being used worldwide all with one primary target that is to use resistance and improve muscle strength. Because strength training has been proved to be beneficial in improving stroke symptoms, it has been included in this study.

Otago Exercise is an evidence-based strength and balance program. It has been shown to be effective in reducing the number of fall and fall related injuries by 35%. The advantages of Otago exercise are that it is cost effective, the exercise protocol is easy to learn and easy to perform. Once learned they can be performed at home by the patient without assistance or by using action observation technique. They are effective in improving lower extremity strength, balance and gait parameters in healthy older adults or people with disorders. This exercise program strengthen the antigravity extensors and increases proprioceptive input of the body by a stable base of support during mobility, thus improving muscle strength and overall improvement in balance control, walking speed and strength. Repeated movement will produce the effect of neuroplasticity in the brain producing efficient, controlled and meaningful movement.

Although Otago exercises are used in previous studies worldwide and showed effectiveness in participants' strength and balance control. Recent evidence suggest that Otago exercises provide high quality results to support its beneficial effects on reducing falls in osteoarthritic patients. It was also observed that this exercise program was safe and helped in improving balance and mobility in Alzheimer's disease. But to our knowledge, there is limited literature available on the use of Otago exercises in chronic stroke patients in Pakistan.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The participants are divided into two groups, group A will be given Otago exercises and grouo B will be given Resistance training.The participants are divided into two groups, group A will be given Otago exercises and grouo B will be given Resistance training.

Masking:

Single (Participant)

Masking Description:

Single Blinded study, participants will be divided into two groups by simple random sampling technique.

Primary Purpose:

Treatment

Official Title:

Comparison of Otago Exercises Versus Resistance Training on Functional Performance in Stroke Patients

Actual Study Start Date :

Sep 5, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A In Group A, Task oriented resistance training will be performed, there will be 5 workstations which include 2 task each given in the table below, after warm up exercises of head, neck, trunk and ankle. Workstation 1: Sitting and reaching in different directions Sit to stand from different chair heights (higher to lower) Workstation 2: Step training (forward, backward, sideways) on blocks Heel lifts-sitting, standing (with and without support) Workstation 3: Reaching with narrow stance (feet in parallel, then in tandem stance) Reciprocal leg flexion and extension Workstation 4: Sit ups Chair stand and walk Workstation 5: Walking race Walking over obstacles This intervention will be given 3 times per week for 4 weeks, every station takes 5-6 minutes and the total intervention will be completed in 50-60 minutes.	Other: Resistance training Task oriented resistance training will be performed, there will be 10 workstations: Sitting at a table and reaching in different directions for objects located beyond arm's length. Sit to stand from various chair heights Stepping forward, backward and sideways onto blocks of various heights. Heel lifts in standing Standing with narrow base of support, feet in parallel and tandem stance and reaching for objects, including down to the floor. Reciprocal leg flexion and extension. Sit ups Standing up from chair, walking a short distance and returning to the chair. Walking races between participants Walking over various surfaces and obstacles
Experimental: Group B Group B will be given Otago exercises, it has 17 exercises in total. 5 for strength and 12 for balance training. First component of intervention starts with head movements followed by neck movements, back extension, trunk movements and ankle movements. Muscle strengthening: Font knee strengthening exercise Back knee strengthening exercise Side hip strengthening exercise Calf raises (with support and without support) Toe raise (with support and without support). Balance Training: Knee bends Backward walking Heel toe standing Heel toe walking One leg stand Heel walking Sideways walk Toe walking Heel toe walking backwards Walk and turn around (figure of 8) Sit to stand Stair walks This intervention will be given 3 times per week for 4 weeks, each session will take 50 minutes to complete. And every exercise is repeated 10 times	Other: Otago Exercises It has total 17 exercises, out of which 12 exercises are performed to improve balance and 5 are performed to improve strength. 1. First component of intervention starts with head movements followed by neck movements, back extension, trunk movements and ankle movements. 2. Second component is muscle strengthening exercises, it includes: i. Front knee strengthening exercise ii. Back knee strengthening exercise iii. Side hip strengthening exercise iv. Calf raises (with support and without support) v. Toe raise (with support and without support). 3. Third component is balance exercises, it includes: i. Knee bends ii. Backward walking iii. Heel toe standing iv. Heel toe walking v. One leg stand vi. Heel walking vii. Sideways walk viii. Toe walking ix. Heel toe walking backwards x. Walk and turn around (figure of 8) xi. Sit to stand xii. Stair walks

Arm

Intervention/Treatment

Experimental: Group A

In Group A, Task oriented resistance training will be performed, there will be 5 workstations which include 2 task each given in the table below, after warm up exercises of head, neck, trunk and ankle. Workstation 1: Sitting and reaching in different directions Sit to stand from different chair heights (higher to lower) Workstation 2: Step training (forward, backward, sideways) on blocks Heel lifts-sitting, standing (with and without support) Workstation 3: Reaching with narrow stance (feet in parallel, then in tandem stance) Reciprocal leg flexion and extension Workstation 4: Sit ups Chair stand and walk Workstation 5: Walking race Walking over obstacles This intervention will be given 3 times per week for 4 weeks, every station takes 5-6 minutes and the total intervention will be completed in 50-60 minutes.

Other: Resistance training

Task oriented resistance training will be performed, there will be 10 workstations: Sitting at a table and reaching in different directions for objects located beyond arm's length. Sit to stand from various chair heights Stepping forward, backward and sideways onto blocks of various heights. Heel lifts in standing Standing with narrow base of support, feet in parallel and tandem stance and reaching for objects, including down to the floor. Reciprocal leg flexion and extension. Sit ups Standing up from chair, walking a short distance and returning to the chair. Walking races between participants Walking over various surfaces and obstacles

Experimental: Group B

Group B will be given Otago exercises, it has 17 exercises in total. 5 for strength and 12 for balance training. First component of intervention starts with head movements followed by neck movements, back extension, trunk movements and ankle movements. Muscle strengthening: Font knee strengthening exercise Back knee strengthening exercise Side hip strengthening exercise Calf raises (with support and without support) Toe raise (with support and without support). Balance Training: Knee bends Backward walking Heel toe standing Heel toe walking One leg stand Heel walking Sideways walk Toe walking Heel toe walking backwards Walk and turn around (figure of 8) Sit to stand Stair walks This intervention will be given 3 times per week for 4 weeks, each session will take 50 minutes to complete. And every exercise is repeated 10 times

Other: Otago Exercises

It has total 17 exercises, out of which 12 exercises are performed to improve balance and 5 are performed to improve strength. 1. First component of intervention starts with head movements followed by neck movements, back extension, trunk movements and ankle movements. 2. Second component is muscle strengthening exercises, it includes: i. Front knee strengthening exercise ii. Back knee strengthening exercise iii. Side hip strengthening exercise iv. Calf raises (with support and without support) v. Toe raise (with support and without support). 3. Third component is balance exercises, it includes: i. Knee bends ii. Backward walking iii. Heel toe standing iv. Heel toe walking v. One leg stand vi. Heel walking vii. Sideways walk viii. Toe walking ix. Heel toe walking backwards x. Walk and turn around (figure of 8) xi. Sit to stand xii. Stair walks

Outcome Measures

Primary Outcome Measures

Dynamometer [4 weeks]
A device that measures force and strength.
4 stage balance test [4 weeks]
To assess static balance There are four standing positions that get progressively harder to maintain. Stand with your feet side-by-side. Place the instep of one foot so it is touching the big toe of the other foot. Tandem stand: Place one foot in front of the other, heel touching toe. Stand on one foot.
Timed Up and Go [4 weeks]
to determine gait speed, balance and fall risk The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated.

Secondary Outcome Measures

Stroke Specific Quality of Life [4 weeks]
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains. Items are rated on a 5-point Likert scale. The total score ranges from 49 to 245, with higher scores indicating a better QOL.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Both genders will be included, age ranging between 40 to 60.
Participants who have had stroke for more than 6 months (chronic stage).
Participant able to stand independently, assessed by 30 second chair stand test.
Participants who can walk with or without assistance

Exclusion Criteria:

Patients with neurological disorders other than stroke i.e., Alzheimer's disease, amyotrophic lateral sclerosis (ALS), brain tumors, cerebral aneurysm.
Patients with impaired cognition or a score of less than 23 out of 30 on Mini-Mental State Exam (MMSE).
Patients with musculoskeletal pathologies like muscular dystrophy
Patients having stroke more than 1 year.
Clotting or bleeding disorder (hemophilia)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shifa Tameer-e-Millat University Islamabad	Islamabad	Fedral	Pakistan	44000

Sponsors and Collaborators

Shifa Tameer-e-Millat University

Investigators

Principal Investigator: Wardah Zafar, MS-PT*, Shifa Tameer-e-millet University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Nouman Khan, Lecturer, Shifa Tameer-e-Millat University

ClinicalTrials.gov Identifier:

NCT06034236

Other Study ID Numbers:

IRB # 0234-23

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nouman Khan, Lecturer, Shifa Tameer-e-Millat University

Otago Exercises

Resistance Training

strength

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Sep 13, 2023