EFFECTS of OTAGO EXERCISES in ADDITION to ROUTINE PHYSICAL THERAPY on BALANCE and FUNCTIONAL ACTIVITIES in PATIENTS with STROKE.

NCT06807879 | Completed DMC

• 1 other identifier: REC-UOL-/380/08/24
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is an extremely severe medical condition which is ranked as the second biggest cause of death worldwide as it claims an estimated 5.5 million lives per year. A stroke can result in enduring brain injury, prolonged disability, or fatality (Tsao et al., 2023) . There are two major types of stroke: Hemorrhagic stroke and Ischemic stroke. The most prevalent type is Ischemic, accounting for approximately 87% of strokes worldwide. It arises from a blockage in a blood vessel supplying the brain (Collaborators, 2022) . Also, the affected brain areas can result in functional limitations, cognitive changes, and emotional difficulties (Fihla, 2024) . Moreover, given the potential cost-effectiveness of OEP compared to more intensive rehabilitation methods, its implementation could offer a pragmatic solution to improving the quality of life for individuals grappling with the enduring consequences of ischemic stroke. Therefore, exploring the effectiveness of OEP in this specific population holds promise for advancing stroke rehabilitation strategies and potentially improving the lives of individuals living with the long-term effects of ischemic stroke.

Conditions

Stroke; Balance; Ischemic Stroke; Function; OEP

Keywords

Otago Exercise; Functional Activities; Balance; Ischemic Stroke; Physical therapy

Outcome Measures

Primary Outcomes (1)

• Balance

  Balance was assessed using the Berg Balance Scale (BBS). To determine the effects of Otago exercises in addition to routine physical therapy on balance and functional activities in patients with stroke.

  Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).

Secondary Outcomes (1)

• Functional activities

  Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).

Study Arms (2)

Modified Otago Exercise with Routine care Physical therapy

EXPERIMENTAL

The modified-OEP group intervention consisted of 15 min of walking followed by a 30 min Otago Exercise Program consisting of balance and strength training, followed by another 15 min of walking. The 15 min walking was accomplished through continuous walking at an individual pace in the \~15 m training room. Participants were asked to walk 15 m, make a U-turn towards the left side, walk 15 m, then make a U-turn towards the right side at the next turning point, in order to achieve an equivalent effect on the promoted benefit of symmetry when turning left and right. This was repeated until the session was complete.

Behavioral: Modified Otago Exercise with Routine care Physical therapy

Routine Care Physical Therapy

EXPERIMENTAL

The routine care physical therapy session typically involves a variety of exercises aimed at general strengthening, stretching, and basic gait training. 1 hour of standard physiotherapy exercises focusing on general strengthening, stretching, and basic gait training.

Behavioral: Routine Care Physical Therapy

Interventions

Modified Otago Exercise with Routine care Physical therapy BEHAVIORAL

To improve the efficacy of the balance improvement intervention, we modified the OEP by incorporating the additional walking, recommended by the OEP guidelines, into a single exercise session and conducting it as a group exercise program in accordance with a previous meta-analysis (Chiu et al., 2021) . As shown in Figure 1, the modified-OEP group intervention consisted of 15 min of walking followed by a 30 min Otago Exercise Program consisting of balance and strength training, followed by another 15 min of walking. The 15 min walking was accomplished through continuous walking at an individual pace in the \~15m training room. Participants were asked to walk 15 m, make a U-turn towards the left side, walk 15 m, then make a U-turn towards the right side at the next turning point, in order to achieve an equivalent effect on the promoted benefit of symmetry when turning left and right. This was repeated until the session was complete.

Modified Otago Exercise with Routine care Physical therapy

Routine Care Physical Therapy BEHAVIORAL

The routine care physical therapy session typically involves a variety of exercises aimed at general strengthening, stretching, and basic gait training. 1 hour of standard physiotherapy exercises focusing on general strengthening, stretching, and basic gait training. The session included a combination of exercises aimed at general strengthening, such as core stability exercises, muscle-strengthening exercises with weights or resistance bands and functional movements like squats and lunges. Stretching exercises targeting key muscle groups like hamstrings will be incorporated to improve flexibility and range of motion. Gait training will focus on activities like side lunges, step-ups, and balance exercises to enhance walking ability and postural control. Additionally, the plan emphasized progressive challenges incorporating a mix of static and dynamic balance exercises using tools like foam pads or balance boards.

Routine Care Physical Therapy

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged between 60 to 70 years old (Verheyden et al., 2013).
• Both genders (Khumpaneid et al., 2022).
• Patients who have been diagnosed with ischemic stroke by a medical professional(Khumpaneid et al., 2022).
• Eligible for movement without using any walking aid equipment (Khumpaneid et al.,2022).
• Exercise less than 150 mins per week (Khumpaneid et al., 2022).
• Timed Up and Go score is more than 10 (Khumpaneid et al., 2022).
• Mini-Mental State Examination (MMSE) score ≥ 24 (Page et al., 2007).
• Urinary and bowel continence (Jin et al., 2023) .

You may not qualify if:

• Patients who have severe cognitive impairment or communication difficulties (Jin et al., 2023).
• Participants who have neurological conditions (e.g., Parkinson's disease), vision problems or contagious diseases (Khumpaneid et al., 2022).
• Patients who have undergone surgery in the past 3 months (Jin et al., 2023

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University Of Lahore Teaching Hospital

Lahore, Punjab Province, 54590, Pakistan

Location

Related Publications (11)

• Khumpaneid N, Phoka T, Khongprasert S. Effects of Modified-Otago Exercise Program on Four Components of Actual Balance and Perceived Balance in Healthy Older Adults. Geriatrics (Basel). 2022 Aug 30;7(5):88. doi: 10.3390/geriatrics7050088.

  PMID: 36136797 BACKGROUND

• Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.

  PMID: 27679565 BACKGROUND

• Farooq A, Venketasubramanian N, Wasay M. Stroke Care in Pakistan. Cerebrovasc Dis Extra. 2021;11(3):118-121. doi: 10.1159/000519554. Epub 2021 Oct 25.

  PMID: 34695824 BACKGROUND

• Everard G, Luc A, Doumas I, Ajana K, Stoquart G, Edwards MG, Lejeune T. Self-Rehabilitation for Post-Stroke Motor Function and Activity-A Systematic Review and Meta-Analysis. Neurorehabil Neural Repair. 2021 Dec;35(12):1043-1058. doi: 10.1177/15459683211048773. Epub 2021 Oct 25.

  PMID: 34696645 BACKGROUND

• Davis JC, Khan KM, Hsu CL, Chan P, Cook WL, Dian L, Liu-Ambrose T. Action Seniors! Cost-Effectiveness Analysis of a Secondary Falls Prevention Strategy Among Community-Dwelling Older Fallers. J Am Geriatr Soc. 2020 Sep;68(9):1988-1997. doi: 10.1111/jgs.16476. Epub 2020 May 29.

  PMID: 32472567 BACKGROUND

• Davis JC, Hsu CL, Barha C, Jehu DA, Chan P, Ghag C, Jacova P, Adjetey C, Dian L, Parmar N, Madden K, Liu-Ambrose T. Comparing the cost-effectiveness of the Otago Exercise Programme among older women and men: A secondary analysis of a randomized controlled trial. PLoS One. 2022 Apr 20;17(4):e0267247. doi: 10.1371/journal.pone.0267247. eCollection 2022.

  PMID: 35442974 BACKGROUND

• Angeles CM, Laura AM, Consuelo CM, Manuel RR, Eva AC, Covadonga GA; Otago Project Working Group. The effect that the Otago Exercise Programme had on fear of falling in community dwellers aged 65-80 and associated factors. Arch Gerontol Geriatr. 2022 Mar-Apr;99:104620. doi: 10.1016/j.archger.2022.104620. Epub 2022 Jan 4.

  PMID: 34999543 BACKGROUND

• Ambrosini E, Peri E, Nava C, Longoni L, Monticone M, Pedrocchi A, Ferriero G, Ferrante S. A multimodal training with visual biofeedback in subacute stroke survivors: a randomized controlled trial. Eur J Phys Rehabil Med. 2020 Feb;56(1):24-33. doi: 10.23736/S1973-9087.19.05847-7. Epub 2019 Sep 26.

  PMID: 31556542 BACKGROUND

• Alsubiheen AM, Choi W, Yu W, Lee H. The Effect of Task-Oriented Activities Training on Upper-Limb Function, Daily Activities, and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Oct 29;19(21):14125. doi: 10.3390/ijerph192114125.

  PMID: 36361001 BACKGROUND

• Albornos-Munoz L, Moreno-Casbas MT, Sanchez-Pablo C, Bays-Moneo A, Fernandez-Dominguez JC, Rich-Ruiz M, Gea-Sanchez M; Otago Project Working Group. Efficacy of the Otago Exercise Programme to reduce falls in community-dwelling adults aged 65-80 years old when delivered as group or individual training. J Adv Nurs. 2018 Jul;74(7):1700-1711. doi: 10.1111/jan.13583. Epub 2018 Jun 3.

  PMID: 29633328 BACKGROUND

• Ahmed, S., Manzoor, F., Naseem, H., & Ansari, A. Q. (2024). Effects of action observation therapy with Otago exercises on balance and quality of life in older adults. The Rehabilitation Journal, 15-21.

  BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Mehwish Saghir, MS Neuro

  University of Lahore

  PRINCIPAL INVESTIGATOR

• Sana Ikram, MS MSK

  University of Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded assessor was considered to minimize bias in outcome measurements. The assessor was unaware of the intervention group assignment for each participant.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: GROUP A :Modified Otago Exercise with Routine care Physical therapy GROUP B :Routine Care Physical Therapy

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: January 25, 2024
• Primary Completion: November 13, 2024
• Study Completion: December 19, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

PA (1)