Chronic StrokeNCT03501186
Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke.
A study testing Backward walking on sand in people with Chronic Stroke, run by Majmaah University at 1 site in Saudi Arabia.
Trial summary
Gait training in stroke is a complex process of motor learning although restoring patients ability to walk would not prepare the individual with the challenges faced in the real environment. The aim is not simply walking in controlled environment, but to achieve dynamic walking. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Backward walking on sand
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Jan 2017to 21 Jul 2018
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had experienced stroke for the first time.
- Unilateral involvement.
- Demonstrate motor stage 3 or 4 on Brunnstrom motor recovery.
- Able to walk 12 m with or without assistive devices.
- Medically stable.
- Able to follow simple commands.
Who cannot join
- Patient exhibits comorbid disease other than stroke that may affect gait.
- Any conditions contra indicated to exercises
- Any other cardio-pulmonary or orthopedic disorders that affects walking ability of the participant.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Khalid Hospital
Al Majma'ah, Riyadh Region, 11952
faizan Z kashoo, Masters, 00966538149226, f.kashoo@mu.edu.sa
shaik A Rahim, PhD, 00966534504703, s.abdulrahim@mu.edu.sa
About this study
Official title: Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke: a Randomized Controlled Trial
Gait training in stroke is a complex process of motor learning although restoring patients ability to walk would not prepare the individual with the challenges faced in the real environment. The aim is not simply walking in controlled environment, but to achieve dynamic walking. Dynamic walking is the ability of an individual to adjust to the changing surfaces and terrains. thereby returning to achieve active participation in the community. Hence, recovery of walking ability is the primary goal when planning treatment for patients with stroke.
- Conditions
- Chronic Stroke
- Being tested
- Backward walking on sand
- Keywords
- Backward walking, stroke, gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward walking on sandOther
Also called forward walking on sand
the patient will be walking backwards on sand with therapist standing close to support in case of fall.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | forward walking on leveled surface Receives: Other: Backward walking on sand |
| Group 2 | Active comparator | forward walking on sand. Receives: Other: Backward walking on sand |
| Group 3 | Experimental | Backward walking on leveled surface Receives: Other: Backward walking on sand |
| Group 4 | Active comparator | Backward walking on sand. Receives: Other: Backward walking on sand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity (m/s)
Measured by Stride Analyser
Measured: 10-15 mins
Cadence (Number of steps per min)
Measured by stride Analyser
Measured: 10-15 mins
Stride length in meters
Measured by stride Analyser
Measured: 10-15 mins
Gait cycle in seconds
Measured by stride Analyser
Measured: 10-15 mins
Secondary outcomes (1)
Barthel index
ADL
Measured: 45 Mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start12 Jan 2017
- Primary completion20 Jun 2018 (estimated)
- Study completion21 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, faizan kashoo, PT, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501186
- Sponsor's protocol ID
- Majmaah
- Status last verified
- May 2018
- First submitted
- 9 Apr 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Stroke Patients
Publications
Makino M, Takami A, Oda A. Comparison of forward walking and backward walking in stroke hemiplegia patients focusing on the paretic side. J Phys Ther Sci. 2017 Feb;29(2):187-190. doi: 10.1589/jpts.29.187. Epub 2017 Feb 24.
PubMed 28265136Kim CY, Lee JS, Kim HD. Comparison of the Effect of Lateral and Backward Walking Training on Walking Function in Patients with Poststroke Hemiplegia: A Pilot Randomized Controlled Trial. Am J Phys Med Rehabil. 2017 Feb;96(2):61-67. doi: 10.1097/PHM.0000000000000541.
PubMed 27323323
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03501186
- Acronym / sponsor ID
- Majmaah
- Conditions
- Chronic Stroke
- Keywords
- Backward walking, stroke, gait training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 20 Jun 2018 (estimated)
- Study completion
- 21 Jul 2018 (estimated)
- First posted
- 18 Apr 2018 (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.
Gait training in stroke is a complex process of motor learning although restoring patients ability to walk would not prepare the individual with the challenges faced in the real environment. The aim is not simply walking in controlled environment, but to achieve dynamic walking. Dynamic walking is the ability of an individual to adjust to the changing surfaces and terrains. thereby returning to achieve active participation in the community. Hence, recovery of walking ability is the primary goal when planning treatment for patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Backward walking on sandforward walking on leveled surface |
| Group 2 | Active comparator | Other: Backward walking on sandforward walking on sand. |
| Group 3 | Experimental | Other: Backward walking on sandBackward walking on leveled surface |
| Group 4 | Active comparator | Other: Backward walking on sandBackward walking on sand. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Had experienced stroke for the first time.
- Unilateral involvement.
- Demonstrate motor stage 3 or 4 on Brunnstrom motor recovery.
- Able to walk 12 m with or without assistive devices.
- Medically stable.
Key exclusion criteria (3 listed)
- Patient exhibits comorbid disease other than stroke that may affect gait.
- Any conditions contra indicated to exercises
- Any other cardio-pulmonary or orthopedic disorders that affects walking ability of the participant.
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 |
|---|---|---|
| Backward walking on sandAlso: forward walking on sandthe patient will be walking backwards on sand with therapist standing close to support in case of fall. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Gait velocity (m/s)
Time frame: 10-15 mins
Measured by Stride Analyser
Cadence (Number of steps per min)
Time frame: 10-15 mins
Measured by stride Analyser
Stride length in meters
Time frame: 10-15 mins
Measured by stride Analyser
Gait cycle in seconds
Time frame: 10-15 mins
Measured by stride Analyser
1 secondary outcome
Barthel index
Time frame: 45 Mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Background: PubMed 28265136Makino M, Takami A, Oda A. Comparison of forward walking and backward walking in stroke hemiplegia patients focusing on the paretic side. J Phys Ther Sci. 2017 Feb;29(2):187-190. doi: 10.1589/jpts.29.187. Epub 2017 Feb 24.
- Background: PubMed 27323323Kim CY, Lee JS, Kim HD. Comparison of the Effect of Lateral and Backward Walking Training on Walking Function in Patients with Poststroke Hemiplegia: A Pilot Randomized Controlled Trial. Am J Phys Med Rehabil. 2017 Feb;96(2):61-67. doi: 10.1097/PHM.0000000000000541.
- Individual participant dataSharing planned: Yes. Stroke Patients
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward walking on sand in people with Chronic Stroke, run by Majmaah 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait velocity (m/s) (time frame: 10-15 mins). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501186, which also lists 2 linked publications.
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 1 Jun 2018.