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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426862
• Other study ID #: REC 01741 Muhammad Baqir
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: Riphah International University
• Contact: Muhammad Baqir, MS
• Phone: +923129008037
• Email: Baqirm409[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 15, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• Control Group
Routine physiotherapy like strengthening, stretching, postural awareness, gait and balance training.

Locations

Country	Name	City	State
Pakistan	Muhammad Baqir	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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