- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05285241
Effects of Multi-direction Stepping and Weight Shifting Exercises in Stroke Patients
March 17, 2022 updated by: Masood Khan, King Saud University
Effects of Multi-direction Stepping and Weight Shifting Exercises on Balance and Gait in Stroke Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Riyadh, Saudi Arabia, 11433
- King Saud University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Multidirectional exercise group
Multidirectional stepping exercises along with conventional physiotherapy were provided to the patients.
Conventional physiotherapy included 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).
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These exercises included stepping of the legs in different directions i.e. sideways, sideways and forefoot (forward), sideways and heel (backward).
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Active Comparator: Conventional Physiotherapy Group
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) were provided to the patients.
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: 4 weeks.
|
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.
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4 weeks.
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Functional gait assessment
Time Frame: 4 weeks.
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The Functional Gait Assessment (FGA) assesses postural stability during walking tasks in persons with gait impairments.
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4 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2016
Primary Completion (Actual)
March 14, 2017
Study Completion (Actual)
May 22, 2017
Study Registration Dates
First Submitted
March 8, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (Actual)
March 17, 2022
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 17, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACP/OP/2016/ OL 06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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San Diego State UniversityCompleted