Effects of Otago Exercise Program in Falls, Balance and Physical Performance in Stroke Patients

To Determine the Effects of the Otago Exercise Program on the Frequency of Falls, Balance Capabilities, and Overall Physical Performance in Stroke Patients.

This study aims to determine the effects of the Otago Exercise Program (OEP) on falls and balance as well as overall physical performance. Participants will be divided into two groups; control and intervention group. It is a week-long study, the participants will be assessed through the Berg Balance Scale (BBS), Time Up and Go (TUG) and Fugl-Meyer Assessment (FMA).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Otago Exercise Program; Other: Control Group

Detailed Description

The previous literature suggested that the Otago exercise showed significant improvement in terms of fall and balance. Most of the Studies were conducted on the elderly population but limited studies are available regarding stroke. This study will look at the effect of Otago exercise on stroke patients. The Otago exercise consists of 17 exercises; strengthening and balancing exercises. The participants will receive Otago exercise and routine physiotherapy treatment for six weeks. The participants will go through three assessments; Baseline Assessment, After 3 weeks assessment and final assessment. For association, a mixed method ANOVA test will be used.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Baqir, MS; Phone Number: +923129008037; Email: Baqirm409@gmail.com

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • Recruiting
      • Muhammad Baqir
      • Contact: Imran Amjad, PhD; Phone Number: +92 332 4390125; Email: imran.amjad@riphah.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ischemic or hemorrhagic stroke
• Medically stable patients with acute to subacute level of stroke recovery (< 6 month).
• Patients 40 plus age
• Berg balance scale <45 and >20 score
• TUG test scoring >20 sec

Exclusion Criteria:

• Participants having cognition problem or language barrier
• Physical disability (fracture or amputation) other than stroke
• Previous surgery 6 weeks
• Cardiovascular and pulmonary disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group; The interventional group will receive both treatment routine physiotherapy and the Otago exercise program (OEP). The OEP is the exercise designed for strength and balance to improve mobility, functional balance and walking. The exercises included in this protocol are 17: strength, balance and walking. The participants will receive this protocol with 10 repetitions while the interval between exercises will not be fixed; patients will be given ample time to relax and recuperate before beginning another exercise, 3 times a week for six weeks and the time duration will be 30 to 45 minutes. The exercises will be progressively administered weekly.	Other: Otago Exercise Program; Otago exercise program Strengthening Exercise Knee extensor, Hip adductors, heel and toe raising Balance exercise Sit to stand, Knee bending, one leg standing, tandem stance, side walk, walk and turn around, tandem walk, backward walk, heel and toe walk, stair climbing; Other: Control Group; Routine physiotherapy like strengthening, stretching, postural awareness, gait and balance training.
Active Comparator: Control group; The control group will receive routine treatment of physiotherapy for strokes like strengthening of upper and lower limb muscles (knee flexor, hip adductor and ankle dorsiflexor), stretching (hip abductors and ankle plantar flexor), postural awareness, gait and balance training like static and dynamic. The participants will be assessed through baseline assessment.	Other: Control Group; Routine physiotherapy like strengthening, stretching, postural awareness, gait and balance training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while >40 represent good balance.	Baseline
Berg Balance Scale	The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while >40 represent good balance.	After 3 weeks
Berg Balance Scale	The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while >40 represent good balance.	After 6 weeks
Time Up & Go Test	The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in >20 seconds are considered as dependent in their activities while those who complete the task in <20 sec indicate independence in ADLs.	Baseline
Time Up & Go Test	The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in >20 seconds are considered as dependent in their activities while those who complete the task in <20 sec indicate independence in ADLs.	After 3 weeks
Time Up & Go Test	The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in >20 seconds are considered as dependent in their activities while those who complete the task in <20 sec indicate independence in ADLs.	After 6 weeks
Fugl-Meyer Assessment	Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory & motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.	Baseline
Fugl-Meyer Assessment	Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory & motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.	After 3 weeks
Fugl-Meyer Assessment	Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory & motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.	After 6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Imran Amjad, Phd, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 19, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 26, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Otago Exercise Program; Berg Balance Scale; Fugl-Meyer Assessment; Cardiovascular Attack; Time Up & Go Test
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REC 01741 Muhammad Baqir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No