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Effects of Multi-direction Stepping and Weight Shifting Exercises in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Multidirectional stepping exercises
Conventional physiotherapy group
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Balance, Gait, Berg balance scale, Functional gait assessment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multidirectional exercise group

Conventional Physiotherapy Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
Functional gait assessment
The Functional Gait Assessment (FGA) assesses postural stability during walking tasks in persons with gait impairments.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2022
Last Updated
March 17, 2022
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05285241
Brief Title
Effects of Multi-direction Stepping and Weight Shifting Exercises in Stroke Patients
Official Title
Effects of Multi-direction Stepping and Weight Shifting Exercises on Balance and Gait in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
May 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Balance, Gait, Berg balance scale, Functional gait assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms parallel design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidirectional exercise group
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional Physiotherapy Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multidirectional stepping exercises
Intervention Description
These exercises included stepping of the legs in different directions i.e. sideways, sideways and forefoot (forward), sideways and heel (backward).
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy group
Intervention Description
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)
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
4 weeks.
Title
Functional gait assessment
Description
The Functional Gait Assessment (FGA) assesses postural stability during walking tasks in persons with gait impairments.
Time Frame
4 weeks.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masood Khan, M.P.Th
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Multi-direction Stepping and Weight Shifting Exercises in Stroke Patients

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