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

NCT06426862 | Recruiting DMC

• 1 other identifier: REC 01741 Muhammad Baqir
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Stroke

Keywords

Stroke; Cardiovascular Attack; Otago Exercise Program; Berg Balance Scale; Time Up & Go Test; Fugl-Meyer Assessment

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Interventional Group

EXPERIMENTAL

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; Other: Control Group

Control group

ACTIVE COMPARATOR

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

Interventions

Otago Exercise Program OTHER

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

Interventional Group

Control Group OTHER

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

Control group; Interventional Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Muhammad Baqir

Peshawar, KPK, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• IMRAN AMJAD, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Baqir, MS

CONTACT

+923129008037; Baqirm409@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: May 23, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 15, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)