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

Sponsor
Shifa Tameer-e-Millat University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05120414
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
1.1
Anticipated Duration (Months)
32.2
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: balanace exercises
  • Other: Balance Exercises plus Ankle strategy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The control and experimental groups were compared with each other.The control and experimental groups were compared with each other.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Ankle Strategy Exercises on Gait Parameters and Balance Confidence in Patients With Chronic Stroke
Actual Study Start Date :
Nov 2, 2021
Anticipated Primary Completion Date :
Dec 2, 2021
Anticipated Study Completion Date :
Dec 6, 2021

Arms and Interventions

ArmIntervention/Treatment
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
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).

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
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).

Outcome Measures

Primary Outcome Measures

  1. ABC scale [4 weeks]

    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%

  2. TUG Test [4 weeks]

    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.

  3. 10 meter walk test [4 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
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:

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Shifa tameer e millat universityIslamabadFederalPakistan44000

Sponsors and Collaborators

  • Shifa Tameer-e-Millat University

Investigators

  • Principal Investigator: Shafaq Altaf, Phd*, Shifa tameer e millat university Islamabad

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nouman Khan, Lecturer, Shifa Tameer-e-Millat University
ClinicalTrials.gov Identifier:
NCT05120414
Other Study ID Numbers:
  • Anam Raiz 168-21
First Posted:
Nov 15, 2021
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nouman Khan, Lecturer, Shifa Tameer-e-Millat University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2021