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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05285241
Other study ID # ACP/OP/2016/ OL 06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2016
Est. completion date May 22, 2017

Study information

Verified date March 2022
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stoke is a leading cause of disability that results not only in persistent neurological deficits but also profound physical de-conditioning that propagates stroke-related secondary disability. Several kinds of research have reported that there has been asymmetrical weight bearing on the affected side while sitting and standing resulting in impaired performance especially reaching in sitting, rising from the chair, walking, and climbing stairs. Despite the stroke patient being able to walk independently with or without the walking aids, the patient still lacks the normal movement pattern especially weight transfers on the affected side while performing such activities which subsequently decreases the patient to restrain the challenges while walking, decrease confidence in functional activities. Also, further, there hasn't been enough literature on this topic. Therefore, the objective of this study is to find out the effectiveness of multidirectional stepping and weight shifting exercises to improve dynamic balance and gait speed in stroke patients.


Description:

The twenty-four subjects who fulfilled the inclusion criteria were selected for the study and were randomly assigned into two groups of 12 subjects each by simple random sampling based on inclusion criteria. First, all the subjects were assessed with a detailed neurological assessment form after the consent form was taken from the patients. The experimental group was given multidirectional stepping exercise with conventional therapy whereas are control group was given only conventional therapy.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 22, 2017
Est. primary completion date March 14, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosed with stroke via CT Scan or MRI - Maintain the independent standing posture for 30 sec - Ability to walk 3 meters independently without an assistive device - Mini-Mental status examination score >21 points - Could communicate and understand therapist's verbal command - Voluntary agreed to participate in the study - Age above 18 years old - Medically stable (e.g. recent myocardial infarction, unstable angina, ventricular tachycardia) Exclusion Criteria: - Visual disorders and visual deficits - History of any neurological pathology like Parkinson's or Alzheimer's disease - Conditions affecting balance like vertigo - Medications affecting balance - Dementia - Impaired conscious level or concomitant medical illness - Lower Motor Neuron lesions - Anti-spasmodic medication (e.g. Baclofen, Dantrolene Sodium, etc.) - Severe orthopedic diseases in lower extremities (e.g. Osteoarthritis, fracture, sprain, strain)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Multidirectional stepping exercises
These exercises included stepping of the legs in different directions i.e. sideways, sideways and forefoot (forward), sideways and heel (backward).
Conventional physiotherapy group
Conventional physiotherapy included a one-to-one range of motion exercises (10min), Strengthening exercises (10 min), Functional mat exercises (10 min), Stretching exercises (5 min), and Gait exercises (10 min)

Locations

Country Name City State
Saudi Arabia King Saud University Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Berg Balance Scale The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Minimum possible value is 0 and maximum possible value is 56. Higher score represents better outcome. 4 weeks.
Primary Functional gait assessment The Functional Gait Assessment (FGA) assesses postural stability during walking tasks in persons with gait impairments. 4 weeks.
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