NCT06034236

Brief Summary

Otago techniques are well known for addressing balance and strength deficiencies in healthy older population with fall risk. Despite this, there is limited literature about the Otago approaches' effectiveness in stroke patients. To the best of our knowledge, no research has been done in Pakistan to determine the effects of Otago exercises on chronic stroke patients.Otago exercises are easy to learn and create a sense of motivation and pleasurable activity when performed. To determine the effect of Otago exercises in treating poor balance control and reduced strength, the current study has chosen chronic stroke patients as its target population. The results of this study will serve as a manual for physical therapists on how to efficiently incorporate Otago Intervention into their treatment plans for better outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

September 5, 2023

Last Update Submit

December 1, 2023

Conditions

Keywords

Otago ExercisesResistance Trainingstrength

Outcome Measures

Primary Outcomes (3)

  • Dynamometer

    A device that measures strength of muscles of lower limb

    4 weeks

  • 4 stage balance test

    To assess static balance There are four standing positions that get progressively harder to maintain. 1. Stand with your feet side-by-side. 2. Place the instep of one foot so it is touching the big toe of the other foot. 3. Tandem stand: Place one foot in front of the other, heel touching toe. 4. Stand on one foot.

    4 weeks

  • Timed Up and Go

    to determine gait speed, balance and fall risk The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated.

    4 weeks

Secondary Outcomes (1)

  • Stroke Specific Quality of Life

    4 weeks

Study Arms (2)

Resistance Training

EXPERIMENTAL

In Group A, Task oriented resistance training will be performed, there will be 5 workstations which include 2 task each given in the table below, after warm up exercises of head, neck, trunk and ankle. Workstation 1: Sitting and reaching in different directions Sit to stand from different chair heights (higher to lower) Workstation 2: Step training (forward, backward, sideways) on blocks Heel lifts-sitting, standing (with and without support) Workstation 3: Reaching with narrow stance (feet in parallel, then in tandem stance) Reciprocal leg flexion and extension Workstation 4: Sit ups Chair stand and walk Workstation 5: Walking race Walking over obstacles This intervention will be given 3 times per week for 4 weeks, every station takes 5-6 minutes and the total intervention will be completed in 50-60 minutes.

Other: Resistance training

Otago Exercises

EXPERIMENTAL

Group B will be given Otago exercises, it has 17 exercises in total. 5 for strength and 12 for balance training. 1. First component of intervention starts with head movements followed by neck movements, back extension, trunk movements and ankle movements. 2. Muscle strengthening: Font knee strengthening exercise Back knee strengthening exercise Side hip strengthening exercise Calf raises (with support and without support) Toe raise (with support and without support). 3. Balance Training: Knee bends Backward walking Heel toe standing Heel toe walking One leg stand Heel walking Sideways walk Toe walking Heel toe walking backwards Walk and turn around (figure of 8) Sit to stand Stair walks This intervention will be given 3 times per week for 4 weeks, each session will take 50 minutes to complete. And every exercise is repeated 10 times

Other: Otago Exercises

Interventions

Task oriented resistance training will be performed, there will be 10 workstations: 1. Sitting at a table and reaching in different directions for objects located beyond arm's length. 2. Sit to stand from various chair heights 3. Stepping forward, backward and sideways onto blocks of various heights. 4. Heel lifts in standing 5. Standing with narrow base of support, feet in parallel and tandem stance and reaching for objects, including down to the floor. 6. Reciprocal leg flexion and extension. 7. Sit ups 8. Standing up from chair, walking a short distance and returning to the chair. 9. Walking races between participants 10. Walking over various surfaces and obstacles

Resistance Training

It has total 17 exercises, out of which 12 exercises are performed to improve balance and 5 are performed to improve strength. 1\. First component of intervention starts with head movements followed by neck movements, back extension, trunk movements and ankle movements. 2\. Second component is muscle strengthening exercises, it includes: i. Front knee strengthening exercise ii. Back knee strengthening exercise iii. Side hip strengthening exercise iv. Calf raises (with support and without support) v. Toe raise (with support and without support). 3. Third component is balance exercises, it includes: i. Knee bends ii. Backward walking iii. Heel toe standing iv. Heel toe walking v. One leg stand vi. Heel walking vii. Sideways walk viii. Toe walking ix. Heel toe walking backwards x. Walk and turn around (figure of 8) xi. Sit to stand xii. Stair walks

Otago Exercises

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders will be included, age ranging between 40 to 60.
  • Participants who have had stroke for more than 6 months (chronic stage).
  • Participant able to stand independently, assessed by 30 second chair stand test.
  • Participants who can walk with or without assistance

You may not qualify if:

  • Patients with neurological disorders other than stroke i.e., Alzheimer's disease, amyotrophic lateral sclerosis (ALS), brain tumors, cerebral aneurysm.
  • Patients with impaired cognition or a score of less than 23 out of 30 on Mini-Mental State Exam (MMSE).
  • Patients with musculoskeletal pathologies like muscular dystrophy
  • Patients having stroke more than 1 year.
  • Clotting or bleeding disorder (hemophilia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa Tameer-e-Millat University Islamabad

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (17)

  • Bohannon RW. Reference values for the timed up and go test: a descriptive meta-analysis. J Geriatr Phys Ther. 2006;29(2):64-8. doi: 10.1519/00139143-200608000-00004.

    PMID: 16914068BACKGROUND
  • Boosman H, Passier PE, Visser-Meily JM, Rinkel GJ, Post MW. Validation of the Stroke Specific Quality of Life scale in patients with aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2010 May;81(5):485-9. doi: 10.1136/jnnp.2009.184960. Epub 2009 Oct 13.

    PMID: 19828480BACKGROUND
  • Christopher A, Kraft E, Olenick H, Kiesling R, Doty A. The reliability and validity of the Timed Up and Go as a clinical tool in individuals with and without disabilities across a lifespan: a systematic review. Disabil Rehabil. 2021 Jun;43(13):1799-1813. doi: 10.1080/09638288.2019.1682066. Epub 2019 Oct 26.

    PMID: 31656104BACKGROUND
  • Dean CM, Richards CL, Malouin F. Task-related circuit training improves performance of locomotor tasks in chronic stroke: a randomized, controlled pilot trial. Arch Phys Med Rehabil. 2000 Apr;81(4):409-17. doi: 10.1053/mr.2000.3839.

    PMID: 10768528BACKGROUND
  • Garland SJ, Ivanova TD, Mochizuki G. Recovery of standing balance and health-related quality of life after mild or moderately severe stroke. Arch Phys Med Rehabil. 2007 Feb;88(2):218-27. doi: 10.1016/j.apmr.2006.11.023.

    PMID: 17270520BACKGROUND
  • Hortobagyi T, Granacher U, Fernandez-Del-Olmo M, Howatson G, Manca A, Deriu F, Taube W, Gruber M, Marquez G, Lundbye-Jensen J, Colomer-Poveda D. Functional relevance of resistance training-induced neuroplasticity in health and disease. Neurosci Biobehav Rev. 2021 Mar;122:79-91. doi: 10.1016/j.neubiorev.2020.12.019. Epub 2020 Dec 28.

    PMID: 33383071BACKGROUND
  • Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.

    PMID: 24339273BACKGROUND
  • Leem SH, Kim JH, Lee BH. Effects of Otago exercise combined with action observation training on balance and gait in the old people. J Exerc Rehabil. 2019 Dec 31;15(6):848-854. doi: 10.12965/jer.1938720.360. eCollection 2019 Dec.

    PMID: 31938708BACKGROUND
  • Park J, Kim TH. The effects of balance and gait function on quality of life of stroke patients. NeuroRehabilitation. 2019;44(1):37-41. doi: 10.3233/NRE-182467.

    PMID: 30741699BACKGROUND
  • Park Y, Chang M. Effects of the Otago exercise program on fall efficacy, activities of daily living and quality of life in elderly stroke patients. J Phys Ther Sci. 2016 Jan;28(1):190-3. doi: 10.1589/jpts.28.190. Epub 2016 Jan 30.

    PMID: 26957755BACKGROUND
  • Severinsen K, Jakobsen JK, Pedersen AR, Overgaard K, Andersen H. Effects of resistance training and aerobic training on ambulation in chronic stroke. Am J Phys Med Rehabil. 2014 Jan;93(1):29-42. doi: 10.1097/PHM.0b013e3182a518e1.

    PMID: 24355995BACKGROUND
  • Son NK, Ryu YU, Jeong HW, Jang YH, Kim HD. Comparison of 2 Different Exercise Approaches: Tai Chi Versus Otago, in Community-Dwelling Older Women. J Geriatr Phys Ther. 2016 Apr-Jun;39(2):51-7. doi: 10.1519/JPT.0000000000000042.

    PMID: 25760277BACKGROUND
  • Suttanon P, Hill KD, Said CM, Williams SB, Byrne KN, LoGiudice D, Lautenschlager NT, Dodd KJ. Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial. Clin Rehabil. 2013 May;27(5):427-38. doi: 10.1177/0269215512460877. Epub 2012 Nov 1.

    PMID: 23117349BACKGROUND
  • Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.

    PMID: 20817938BACKGROUND
  • Wechsler LR, Bates D, Stroemer P, Andrews-Zwilling YS, Aizman I. Cell Therapy for Chronic Stroke. Stroke. 2018 May;49(5):1066-1074. doi: 10.1161/STROKEAHA.117.018290. Epub 2018 Apr 18. No abstract available.

    PMID: 29669865BACKGROUND
  • Xie C, Wang W, Pei J, Wang H, Lv H. Effect of otago exercise on falls in patients with osteoarthritis: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Dec 11;99(50):e23559. doi: 10.1097/MD.0000000000023559.

    PMID: 33327309BACKGROUND
  • Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.

    PMID: 36339194BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wardah Zafar, MS-PT*

    Shifa Tameer-e-millet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Blinded study, participants will be divided into two groups by simple random sampling technique.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The participants are divided into two groups, group A will be given Otago exercises and grouo B will be given Resistance training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

September 5, 2023

Primary Completion

November 1, 2023

Study Completion

November 10, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations