StrokeNCT05285241
Effects of Multi-direction Stepping and Weight Shifting Exercises in Stroke Patients
A study testing Multidirectional stepping exercises and Conventional physiotherapy group in people with Stroke, run by King Saud University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Multidirectional stepping exercises and Conventional physiotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 May 2016to 22 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Multidirectional stepping exercises, Conventional physiotherapy group
- Keywords
- Stroke, Balance, Gait, Berg balance scale, Functional gait assessment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidirectional stepping exercisesOther
These exercises included stepping of the legs in different directions i.e. sideways, sideways and forefoot (forward), sideways and heel (backward).
Conventional physiotherapy groupOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Multidirectional exercise group | Experimental | 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). Receives: Other: Multidirectional stepping exercises |
| Conventional Physiotherapy Group | Active comparator | 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. Receives: Other: Conventional physiotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks.
Functional gait assessment
The Functional Gait Assessment (FGA) assesses postural stability during walking tasks in persons with gait impairments.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start11 May 2016
- Primary completion14 Mar 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms parallel design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285241
- Sponsor's protocol ID
- ACP/OP/2016/ OL 06
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multi-direction Stepping and Weight Shifting Exercises on Balance and Gait in Stroke Patients
- ClinicalTrials.gov ID
- NCT05285241
- Acronym / sponsor ID
- ACP/OP/2016/ OL 06
- Conditions
- Stroke
- Keywords
- Stroke, Balance, Gait, Berg balance scale, Functional gait assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 11 May 2016 (actual)
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms parallel design
| Arm | Type | Receives |
|---|---|---|
| Multidirectional exercise group | Experimental | Other: Multidirectional stepping exercisesMultidirectional 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). |
| Conventional Physiotherapy Group | Active comparator | Other: Conventional physiotherapy groupOne-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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidirectional stepping exercisesThese exercises included stepping of the legs in different directions i.e. sideways, sideways and forefoot (forward), sideways and heel (backward). | Other | Multidirectional exercise group |
| Conventional physiotherapy groupConventional 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) | Other | Conventional Physiotherapy Group |
Primary outcome
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.
Functional gait assessment
Time frame: 4 weeks.
The Functional Gait Assessment (FGA) assesses postural stability during walking tasks in persons with gait impairments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masood Khan, M.P.Th principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidirectional stepping exercises and Conventional physiotherapy group in people with Stroke, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.