Clinical trial NCT06807879: EFFECTS of OTAGO EXERCISES in ADDITION to ROUTINE PHYSICAL THERAPY on BALANCE and FUNCTIONAL ACTIVITIES in PATIENTS with STROKE.
Official title: EFFECTS of OTAGO EXERCISES in ADDITION to ROUTINE PHYSICAL THERAPY on BALANCE and FUNCTIONAL ACTIVITIES in PATIENTS with STROKE.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Balance
Ischemic Stroke
Function
OEP
Keywords: Otago Exercise
Functional Activities
Balance
Ischemic Stroke
Physical therapy
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: GROUP A :Modified Otago Exercise with Routine care Physical therapy GROUP B :Routine Care Physical Therapy
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Study Design: Randomized Clinical Trial.

Screening:

Patients were screened to meet inclusion criteria. The consent form taken from patients then patients were randomly allocated into two groups ( 29 in each group).

Randomization:

Using the lottery approach, patients who met the inclusion criteria were split into experimental and control groups at random by the online tool for randomization.

Blinding:

To ensure precision and mitigating the bias the assessor of outcome was kept blind also. An independent assessor specialized in this technique and having more than 5 years experience screened patients, and they were subsequently randomly assigned to either the experimental group. The computer-generated allocation sequence was established prior to the study's commencement.

Assessment:

Data was collected at baseline, fourth week and then at the end of the eighth week. Baseline assessments will be conducted before the intervention. Post-intervention assessments will be conducted immediately after the intervention. Statistical analysis will include descriptive statistics, t-tests, and analysis of variance to compare the outcomes between the two groups.

Intervention:

The intervention group A received routine physical therapy in addition to the Otago Exercise Program, while the control group B received routine physical therapy alone.

GROUP A: ( Modified Otago Exercise with Routine care Physical therapy) GROUP B: ( ROUTINE CARE PHYSICAL THERAPY )

Outcome Measures:

Primary outcome:

Balance was assessed using the Berg Balance Scale (BBS)

Secondary outcomes:

Functional activities the physical performance was assessed using the 30-s Chair Stand Test (30 s-CST).

Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.

Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.

Eligibility criteria: Inclusion Criteria:

* 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) .

Exclusion Criteria:

* 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

Primary outcomes:
measure: Balance
timeFrame: Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
Secondary outcomes:
measure: Functional activities
timeFrame: Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University Of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: University of Lahore
name: Mehwish Saghir, MS Neuro
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lahore
name: Sana Ikram, MS MSK
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Ahmed, S., Manzoor, F., Naseem, H., &amp; 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.