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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
balanace exercises
Balance Exercises plus Ankle strategy
Sponsored by
Shifa Tameer-e-Millat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Ankle strategy, Balance exercises, Gait, stroke

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Shifa tameer e millat universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%
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.
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

Secondary Outcome Measures

Full Information

First Posted
November 2, 2021
Last Updated
November 2, 2021
Sponsor
Shifa Tameer-e-Millat University
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1. Study Identification

Unique Protocol Identification Number
NCT05120414
Brief Title
Effect of Ankle Strategy Exercises on Gait Parameters and Balance Confidence in Patients With Chronic Stroke
Official Title
Effect of Ankle Strategy Exercises on Gait Parameters and Balance Confidence in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
December 2, 2021 (Anticipated)
Study Completion Date
December 6, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Tameer-e-Millat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Ankle strategy, Balance exercises, Gait, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The control and experimental groups were compared with each other.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
balanace exercises
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Balance Exercises plus Ankle strategy
Intervention Description
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).
Primary Outcome Measure Information:
Title
ABC scale
Description
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
Title
TUG Test
Description
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
Title
10 meter walk test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shafaq Altaf, Phd*
Phone
03435020507
Email
shafaq_dpt.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Nouman Khan, MS-OMPT
Phone
03339378324
Email
nouman_drs.ahs@stmu.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shafaq Altaf, Phd*
Organizational Affiliation
Shifa tameer e millat university Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shifa tameer e millat university
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shafaq Altaf, Phd*
Phone
03435020507
Email
shafaq_dpt.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Nouman Khan, Ms- OMPT
Phone
03339378324
Email
nouman_drs.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Anam Riaz, MSNMPT*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12677087
Citation
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.
Results Reference
background
PubMed Identifier
7678184
Citation
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.
Results Reference
background
PubMed Identifier
27078115
Citation
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.
Results Reference
background
PubMed Identifier
19903653
Citation
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.
Results Reference
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PubMed Identifier
26644684
Citation
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.
Results Reference
background
PubMed Identifier
22494388
Citation
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.
Results Reference
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PubMed Identifier
28154098
Citation
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.
Results Reference
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PubMed Identifier
25547769
Citation
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.
Results Reference
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PubMed Identifier
21081029
Citation
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.
Results Reference
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Effect of Ankle Strategy Exercises on Gait Parameters and Balance Confidence in Patients With Chronic Stroke

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