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Status unknownNCT05120414Updated Nov 15, 2021

Effect of Ankle Strategy Exercises on Gait Parameters and Balance Confidence in Patients With Chronic Stroke

An interventional study of balanace exercises and Balance Exercises plus Ankle strategy in Stroke, sponsored by Shifa Tameer-e-Millat University. Status unknown at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-11-15.

Sponsored by Shifa Tameer-e-Millat University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study summary

Stroke is a disorder in which the areas of the brain that control the sensory and motor nerves are damaged due to poor blood supply to the brain. As a result of which oxygen and nutrients supply to the brain tissues is interrupted. This is either caused by infarction or a bleed in the blood arteries supplying the brain. A stroke occurs when the cerebral blood supply is disrupted, resulting in a localized neurological deficiency. At least 80% of strokes are ischemic, meaning they are caused by a blockage in blood flow, while 15-20% are caused by bleeding into the brain, known as intracerebral hemorrhage. The occurrence of the sudden neurological deficit caused by bleeding in the brain or ischemic damage gives rise to the disturbances in motion, senses, perception, language, and other such functions on the opposite side to the affected side of the brain. A randomized controlled trial was carried out on 36 chronic stroke patients. By using the sealed envelope method, the sample was divided into two groups, an experimental group and a control group. For a period of four weeks, the control group only received traditional balancing exercises including standing with feet together, standing with one foot directly in front of the other, standing eye open to eye closed, standing multidirectional functional reach and March in place and walk sideways. While the experimental group received ankle strategy exercises in addition to balance exercises which included raising and lowering heels and forefeet, heel to toe walking, stepping up and down and left right and diagonal inclination of the body during standing. Interventions were given three days weekly for four consecutive weeks. Pre and post-intervention assessment were done by using data collection tools which includes ABC Scale of balance confidence, TUG scale and 10meter walk test.

Read the detailed description

Stroke was defined in 1970 by the World Health Organization as "Rapidly acquired clinical symptoms of focal (or global) impairment of brain function 24-48 hours or resulting in death, with no evident cause other than a vascular origin." A stroke occurs when the cerebral Epidemiology, Incidence and Prevalence Epidemiologic research on stroke aids in the knowledge of the disease's natural history, the early diagnosis, and the prediction of prognosis, all of which can lead to indicators for disease mechanisms. Women and men have differences concerning stroke. As compared to men, women have an increased lifetime risk of stroke and they have a higher prcentage of disability, dementia and depression. Stroke is a non-communicable disease that is becoming more prevalent as the population ages. In many nations, it is the prime cause of mortality and disability. America has seen a decrease in stroke mortality in the last twenty years, but recent trends show that these decreases may have leveled off. In 2013, there were around 25.7 million stroke survivors, 6.5 million stroke fatalities, 113 million disability-adjusted life-years (DALYs) lost due to stroke, and up to 10.3 million incidences of new stroke. Stroke has become the biggest cause of persistent impairment in the United States, as well as the second most leading cause of dementia and the fourth most common cause of mortality. The is high morbidity associated with stroke, with costs estimated at $34 billion annually for healthcare services, medications, and missed workdays. In the United States, about 800,000 primary (first-time) or secondary (recurrent) strokes happen annually, with primary strokes accounting for the majority (roughly 600,000). Although the proportional burden of hemorrhagic vs ischemic stroke varies among various populations, the majority of strokes (80% ) are ischemic . Stroke appears to have an even greater global impact than it does in the United States.

Hemiparesis, hemisensory loss, impaired language, eye muscle weakness, and visual field cuts are all symptoms of cerebral bleed and infarction, which cause sudden malfunctioning of neurologic tissue. In contrast, cerebral hemorrhage causes blood to flow into the brain. This causes squeezing of neighboring tissue and eventually increased intracranial pressure. As a result due to this increased pressure and meningeal irritation, the patient presents with severe headache, neck stiffness and vomiting and progressive deterioration due to continuous bleeding.

02

Conditions studied

  • Stroke

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Keywords

  • Ankle strategy
  • Balance exercises
  • Gait
  • stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 36 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Shifa Tameer-e-Millat University is the lead sponsor of 26 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Both male and female with Hemiplegic stroke (unilateral) Age between 40 and 60 years Chronic stroke patients were included (patients who had a stroke more than 3 months ago)

Exclusion criteria

Exclusion Criteria:

PCA Stroke patients with cortical blindness Patients who have had more than one stroke Patients with active medical complications Patients with concomitant gait disorders due to acute or subacute Musculoskeletal issues

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    Control

    patients in control group did balance exercises for period of 4 weeks (10 repetitions in each set, 3 sets per session, 1 session daily, 3 days weekly.) The exercises included standing with feet together, Standing in Tandem position, Standing eye open to eye closed, multidirectional functional reach during standing, March in place and walk sideways.

    Other: balanace exercises

  • Experimental
    Experimental

    Experimental group received ankle strategy exercises in addition to balance exercises for a period of 4 weeks (10 repetitions in each set, 3 sets per session, 1 session daily, 3 days weekly). Ankle strategy exercises included raising and lowering heels and forefeet, heel to toe walking, stepping up and down and right and left and diagonal inclination of body during standing.

    Other: Balance Exercises plus Ankle strategy

Interventions

  • Otherbalanace exercises

    Balance exercises included standing with feet together (narrow base of support), Standing in Tandem position, Standing eye open to eye closed, multidirectional functional reach during standing, March in place and walk sideways. Time period was of 4 weeks (10 repetitions in each set, 3 sets per session, 1 session daily, 3 days weekly).

  • OtherBalance Exercises plus Ankle strategy

    ankle strategy exercises included raising and lowering heels and forefeet, heel to toe walking, stepping up and down and right and left and diagonal inclination of body during standing.While balance exercises included standing with feet together (narrow base of support), Standing in Tandem position, Standing eye open to eye closed, multidirectional functional reach during standing, March in place and walk sideways. Time period was of 4 weeks (10 repetitions in each set, 3 sets per session, 1 session daily, 3 days weekly).

06

What researchers measure

Primary outcomes

  1. ABC scale

    In this patient himself reported the level of confidence in doing certain activities by choosing one of the percentages on the scale from 0% to 100%

    Time frame: 4 weeks

  2. TUG Test

    The participant was requested to get out of a chair, walk 3 meters, turn around, return to the chair, and sit on it. We had utilized it to measure dynamic balance in this study.

    Time frame: 4 weeks

  3. 10 meter walk test

    This was used for Quantitative gait analysis. Different Temporal-spatial parameters were assessed including gait speed (in meter per second), cadence (with a stopwatch), step length and stride length (with marker method). In 10meter walk test patient is instructed to walk on a 14 meters straight pathway in which only the middle 10 meters are recorded

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Shifa tameer e millat university
    Islamabad, Federal 44000, Pakistan
    Recruiting
08

References and documents

Publications

  • Adams HP Jr, Adams RJ, Brott T, del Zoppo GJ, Furlan A, Goldstein LB, Grubb RL, Higashida R, Kidwell C, Kwiatkowski TG, Marler JR, Hademenos GJ; Stroke Council of the American Stroke Association. Guidelines for the early management of patients with ischemic stroke: A scientific statement from the Stroke Council of the American Stroke Association. Stroke. 2003 Apr;34(4):1056-83. doi: 10.1161/01.STR.0000064841.47697.22. No abstract available. PubMed 12677087 ↗
  • Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35. PubMed 7678184 ↗
  • Aidar FJ, de Oliveira RJ, de Matos DG, Mazini Filho ML, Moreira OC, de Oliveira CE, Hickner RC, Reis VM. A Randomized Trial Investigating the Influence of Strength Training on Quality of Life in Ischemic Stroke. Top Stroke Rehabil. 2016 Apr;23(2):84-9. doi: 10.1080/10749357.2015.1110307. Epub 2016 Jan 29. PubMed 27078115 ↗
  • Arene N, Hidler J. Understanding motor impairment in the paretic lower limb after a stroke: a review of the literature. Top Stroke Rehabil. 2009 Sep-Oct;16(5):346-56. doi: 10.1310/tsr1605-346. PubMed 19903653 ↗
  • Bae YH, Ko Y, Ha H, Ahn SY, Lee W, Lee SM. An efficacy study on improving balance and gait in subacute stroke patients by balance training with additional motor imagery: a pilot study. J Phys Ther Sci. 2015 Oct;27(10):3245-8. doi: 10.1589/jpts.27.3245. Epub 2015 Oct 30. PubMed 26644684 ↗
  • Batchelor FA, Mackintosh SF, Said CM, Hill KD. Falls after stroke. Int J Stroke. 2012 Aug;7(6):482-90. doi: 10.1111/j.1747-4949.2012.00796.x. Epub 2012 Apr 12. PubMed 22494388 ↗
  • Boehme AK, Esenwa C, Elkind MS. Stroke Risk Factors, Genetics, and Prevention. Circ Res. 2017 Feb 3;120(3):472-495. doi: 10.1161/CIRCRESAHA.116.308398. PubMed 28154098 ↗
  • Bonnyaud C, Pradon D, Zory R, Bensmail D, Vuillerme N, Roche N. Gait parameters predicted by Timed Up and Go performance in stroke patients. NeuroRehabilitation. 2015;36(1):73-80. doi: 10.3233/NRE-141194. PubMed 25547769 ↗
  • Bryer A, Connor M, Haug P, Cheyip B, Staub H, Tipping B, Duim W, Pinkney-Atkinson V. South African guideline for management of ischaemic stroke and transient ischaemic attack 2010: a guideline from the South African Stroke Society (SASS) and the SASS Writing Committee. S Afr Med J. 2010 Nov 10;100(11 Pt 2):747-78. doi: 10.7196/samj.4422. PubMed 21081029 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05120414
Lead sponsor
Shifa Tameer-e-Millat University
Responsible party
Nouman Khan (Lecturer, Shifa Tameer-e-Millat University) — Principal investigator
First posted
Nov 15, 2021
Start date
Nov 2, 2021
Primary completion
Dec 2, 2021 (estimated)
Completion
Dec 6, 2021 (estimated)
Last update
Nov 15, 2021

Study contacts

Shafaq Altaf, Phd*
Contact
shafaq_dpt.ahs@stmu.edu.pk
03435020507
Nouman Khan, MS-OMPT
Contact
nouman_drs.ahs@stmu.edu.pk
03339378324
Shafaq Altaf, Phd*
principal investigator · Shifa tameer e millat university Islamabad

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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