StrokeNCT04192240
Weight-bearing Training in Stroke Patients.
A study testing WB Training with external feedback and WB Training without external feedback in people with Stroke, run by Khon Kaen University at 1 site in Thailand.
Trial summary
1. Are there differences in weight-bearing (WB) and WB symmetry immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke? 1. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- WB Training with external feedback and WB Training without external feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2019to 25 Oct 2020
- 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Independent ambulatory patients with chronic stroke (post-stroke time more than 6 months)
- Age at least 40 years to 74 years
- Body mass index (BMI) between 18.5- 29.9 kg/m^2
- Ability of independent walking over at least 10 meters with or without a walking device
- Ability to rise from a chair with or without using their arms
- Ability to follow a command used in the study
Who cannot join
- any conditions that may affect ambulatory ability or ability to participate in the study, such as
- Auditory or visual deficits that are unable to be corrected by a hearing aid, glasses or contact lens
- Musculoskeletal pain with a pain scale more than 5 out of 10 on a visual analog scale (VAS)
- Deformity in the limbs or spine that affect ambulatory ability
- Modified Ashworth Scale (MAS) more 2 score
- Unstable cardiovascular, orthopedics, musculoskeletal, or neurological disease other than stroke.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Associated Medical Science
Nai Muang, KhonKaen, 40002
About this study
Official title: Immediate Effects of Lower Limb Loading Training During Sit-to-stand and Stepping With and Without External Feedback in Ambulatory Individuals With Stroke
- Are there differences in weight-bearing (WB) and WB symmetry immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?
- Are there differences in mobility immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?
Read the detailed description
Subjects are patients with stroke, the age of over 40 years to 74 years, both males and females who are able to walk independently at least 10 meters. Most of them will be recruited from a tertiary rehabilitation center and communities. Subjects have to participate in STS and stepping training with and without using the external feedback for 1 time/condition with a wash-out period for 2 weeks (crossover design). The outcomes will be measured in terms of WB ability during STS and stepping, walking speed, and balance ability.
The primary outcomes were WB ability on the affected limb and WB symmetry. Secondary outcomes were walking speed and balance ability.
- Conditions
- Stroke
- Being tested
- WB Training with external feedback, WB Training without external feedback
- Keywords
- cerebrovascular disease, rehabilitation, walking, balance, mobility
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB Training with external feedbackOther
WB during sit-to-stand and stepping with external feedback, follow by overground walking.
WB Training without external feedbackOther
WB during sit-to-stand and stepping without external feedback, follow by overground walking.
| Study group | Role | What they receive |
|---|---|---|
| WB Training with external feedback | Experimental | WB during sit-to-stand with external feedback for 10 minute and then, WB during stepping training with external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes. Receives: Other: WB Training with external feedback |
| WB Training without external feedback | Active comparator | WB during sit-to-stand without external feedback for 10 minute and then, WB during stepping training without external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes. Receives: Other: WB Training without external feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-bearing (WB) ability and WB symmetry
Measured: Prior to and immediately after complete training program in one session
Secondary outcomes (2)
Walking speed using the 10 meter-walk test (10MWT)
Measured: Prior to and immediately after complete training program in one session
Dynamic balance control using the Timed up and go test (TUGT)
Measured: Prior to and immediately after complete training program in one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jun 2019
- Primary completion19 Oct 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugalya Amatachaya, Khon Kaen University
- Investigators
- Sugalya Amatachaya, Principal investigator, School of physical therapy, Faculty of Associated medical sciences, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192240
- Sponsor's protocol ID
- MSD60I0015
- Status last verified
- Apr 2022
- First submitted
- 10 Mar 2019
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boukadida A, Piotte F, Dehail P, Nadeau S. Determinants of sit-to-stand tasks in individuals with hemiparesis post stroke: A review. Ann Phys Rehabil Med. 2015 Jun;58(3):167-72. doi: 10.1016/j.rehab.2015.04.007. Epub 2015 May 23.
PubMed 26004813Lomaglio MJ, Eng JJ. Muscle strength and weight-bearing symmetry relate to sit-to-stand performance in individuals with stroke. Gait Posture. 2005 Oct;22(2):126-31. doi: 10.1016/j.gaitpost.2004.08.002.
PubMed 16139747Park GD, Choi JU, Kim YM. The effects of multidirectional stepping training on balance, gait ability, and falls efficacy following stroke. J Phys Ther Sci. 2016 Jan;28(1):82-6. doi: 10.1589/jpts.28.82. Epub 2016 Jan 30.
PubMed 26957733Tsaklis PV, Grooten WJ, Franzen E. Effects of weight-shift training on balance control and weight distribution in chronic stroke: a pilot study. Top Stroke Rehabil. 2012 Jan-Feb;19(1):23-31. doi: 10.1310/tsr1901-23.
PubMed 22306625
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Lower Limb Loading Training During Sit-to-stand and Stepping With and Without External Feedback in Ambulatory Individuals With Stroke
- ClinicalTrials.gov ID
- NCT04192240
- Acronym / sponsor ID
- MSD60I0015
- Conditions
- Stroke
- Keywords
- cerebrovascular disease, rehabilitation, walking, balance, mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 10 Dec 2019 (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.
- Are there differences in weight-bearing (WB) and WB symmetry immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?
- Are there differences in mobility immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?
Detailed description
Subjects are patients with stroke, the age of over 40 years to 74 years, both males and females who are able to walk independently at least 10 meters. Most of them will be recruited from a tertiary rehabilitation center and communities. Subjects have to participate in STS and stepping training with and without using the external feedback for 1 time/condition with a wash-out period for 2 weeks (crossover design). The outcomes will be measured in terms of WB ability during STS and stepping, walking speed, and balance ability.
The primary outcomes were WB ability on the affected limb and WB symmetry. Secondary outcomes were walking speed and balance ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WB Training with external feedback | Experimental | Other: WB Training with external feedbackWB during sit-to-stand with external feedback for 10 minute and then, WB during stepping training with external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes. |
| WB Training without external feedback | Active comparator | Other: WB Training without external feedbackWB during sit-to-stand without external feedback for 10 minute and then, WB during stepping training without external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Independent ambulatory patients with chronic stroke (post-stroke time more than 6 months)
- Age at least 40 years to 74 years
- Body mass index (BMI) between 18.5- 29.9 kg/m^2
- Ability of independent walking over at least 10 meters with or without a walking device
- Ability to rise from a chair with or without using their arms
Key exclusion criteria (6 listed)
- any conditions that may affect ambulatory ability or ability to participate in the study, such as
- Auditory or visual deficits that are unable to be corrected by a hearing aid, glasses or contact lens
- Musculoskeletal pain with a pain scale more than 5 out of 10 on a visual analog scale (VAS)
- Deformity in the limbs or spine that affect ambulatory ability
- Modified Ashworth Scale (MAS) more 2 score
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 |
|---|---|---|
| WB Training with external feedbackWB during sit-to-stand and stepping with external feedback, follow by overground walking. | Other | WB Training with external feedback |
| WB Training without external feedbackWB during sit-to-stand and stepping without external feedback, follow by overground walking. | Other | WB Training without external feedback |
Primary outcome
Weight-bearing (WB) ability and WB symmetry
Time frame: Prior to and immediately after complete training program in one session
2 secondary outcomes
Walking speed using the 10 meter-walk test (10MWT)
Time frame: Prior to and immediately after complete training program in one session
Dynamic balance control using the Timed up and go test (TUGT)
Time frame: Prior to and immediately after complete training program in one session
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 25 Apr 2022.
- Results publication: PubMed 26004813Boukadida A, Piotte F, Dehail P, Nadeau S. Determinants of sit-to-stand tasks in individuals with hemiparesis post stroke: A review. Ann Phys Rehabil Med. 2015 Jun;58(3):167-72. doi: 10.1016/j.rehab.2015.04.007. Epub 2015 May 23.
- Results publication: PubMed 16139747Lomaglio MJ, Eng JJ. Muscle strength and weight-bearing symmetry relate to sit-to-stand performance in individuals with stroke. Gait Posture. 2005 Oct;22(2):126-31. doi: 10.1016/j.gaitpost.2004.08.002.
- Results publication: PubMed 26957733Park GD, Choi JU, Kim YM. The effects of multidirectional stepping training on balance, gait ability, and falls efficacy following stroke. J Phys Ther Sci. 2016 Jan;28(1):82-6. doi: 10.1589/jpts.28.82. Epub 2016 Jan 30.
- Results publication: PubMed 22306625Tsaklis PV, Grooten WJ, Franzen E. Effects of weight-shift training on balance control and weight distribution in chronic stroke: a pilot study. Top Stroke Rehabil. 2012 Jan-Feb;19(1):23-31. doi: 10.1310/tsr1901-23.
- Individual participant dataSharing planned: No
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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.
Sugalya Amatachaya principal investigator
School of physical therapy, Faculty of Associated medical sciences, Khon Kaen 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 WB Training with external feedback and WB Training without external feedback in people with Stroke, run by Khon Kaen University at 1 site in Thailand.
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 6 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 25 Apr 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 Thailand. 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?
Weight-bearing (WB) ability and WB symmetry (time frame: Prior to and immediately after complete training program in one session). 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 NCT04192240, which also lists 4 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 25 Apr 2022.