StrokeNCT03273101
Sit-to-stand Training in Stroke Patient
A study testing Mechanical assisted sit-to-stand training group and Manual assisted sit-to-stand training group in people with Stroke, run by Tai Po Hospital.
Trial summary
Background: It is unknown whether the self-initiated sit-to-stand training with assistive device is effective to regain the independence of sit-to-stand in stroke patients. Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive device, with manual sit-to-stand training. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Mechanical assisted sit-to-stand training group and Manual assisted sit-to-stand training group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- first episode of unilateral stroke with hemiparesis,
- able to understand and follow simple verbal instructions,
- able to sit unsupported for at least two minutes
- require lifting assistance to stand up from a 18 inches high plinth
Who cannot join
- severe pain in the lower extremities when weight bearing or performing movement
- any other acute comorbid diseases such as unstable angina, recent myocardial infarction
- unstable medical / psychological condition
About this study
Official title: Does Self-initiated Sit-to-stand Training With Assistive Device Regain the Independence of Sit-to-stand in Stroke Patient? A Single-blinded Randomised Controlled Trial.
Background: It is unknown whether the self-initiated sit-to-stand training with assistive device is effective to regain the independence of sit-to-stand in stroke patients.
Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive device, with manual sit-to-stand training.
Read more
Design: Parallel randomised controlled and assessor blinded trial between Jan 2015 and May 2018. Randomisation was performed by drawing lots to allocate treatment to patient.
Setting: A rehabilitation hospital in Hong Kong
Participants: 69 patients in medical wards with unilateral hemiparetic stroke. 52 patients fulfilled the study requirements.
Intervention: Ten sessions of intervention with conventional physiotherapy program followed, by self-initiated sit-to-stand training with assistive device, or by manual sit-to-stand training.
Main outcome measure: Number of patients regained the independence of sit-to-stand, Sit-to-stand test from the balance master® and Five-repetitions sit-to-stand test.
Results: 69 patients (intervention n=36; control n=33) were randomized (mean age 69.8 (SD, 10.6), mean post stroke days 18.6 (SD 16.0)) for intention to treat analysis. 17 patients were excluded because of dropout before 10 sessions of training, leaving 52 (n=26; n=26) patients for per protocol analysis. 18 patients in intervention group and 10 patients in control group had regained the independence of sit-to-stand (Phil and Cramer's V: -0.31 and 0.31). The patients in intervention group were faster to complete the Five-repetition sit-to-stand test than the control group (32.7 secs (SD, 1.93) v 48.4 secs (SD, 6.8); 95% confidence interval, -30.8 to -0.7; p<0.05). No adverse side effects occurred during and after the training across groups.
Conclusions: Self-initiated sit-to-stand training by assistive device can help more stroke patients regain the independence of sit-to-stand.
- Conditions
- Stroke
- Being tested
- Mechanical assisted sit-to-stand training group, Manual assisted sit-to-stand training group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical assisted sit-to-stand training groupDevice
Also called sit-to-stand trainer
Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
Manual assisted sit-to-stand training groupOther
Also called physiotherapist assisted
Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The sit-to-stand training is assisted by mechanical device Receives: Device: Mechanical assisted sit-to-stand training group |
| Control group | Active comparator | The sit-to-stand training is assisted by manual device Receives: Other: Manual assisted sit-to-stand training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients regained the independence of sit-to-stand
To compare how many patients can regain the independence of sit-to-stand between groups
Measured: After 10 sessions of training
Sit-to-Stand Test (SST) from the Balance Master®
To assess the quality of sit-to-stand of patient
Measured: After 10 sessions of training
Five-Repetition Sit-to-Stand Test
To assess the functional strength of lower limb, balance and transition move of patient
Measured: After 10 sessions of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study startJan 2015
- Primary completionMar 2017
- Study completionMay 2018
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tai Po Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ng Chee Man, Joey, Tai Po Hospital
- Investigators
- Ng Chee Man, Joey, Master, Principal investigator, Tai Po HospitalWoo Ka Ho, Marc, Master, Study director, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273101
- Sponsor's protocol ID
- 2014.427
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2017
- Last updated
- 6 Sep 2018
- 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Self-initiated Sit-to-stand Training With Assistive Device Regain the Independence of Sit-to-stand in Stroke Patient? A Single-blinded Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03273101
- Acronym / sponsor ID
- 2014.427
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tai Po HospitalOther government
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 6 Sep 2017 (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.
Background: It is unknown whether the self-initiated sit-to-stand training with assistive device is effective to regain the independence of sit-to-stand in stroke patients.
Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive device, with manual sit-to-stand training.
Design: Parallel randomised controlled and assessor blinded trial between Jan 2015 and May 2018. Randomisation was performed by drawing lots to allocate treatment to patient.
Setting: A rehabilitation hospital in Hong Kong
Participants: 69 patients in medical wards with unilateral hemiparetic stroke. 52 patients fulfilled the study requirements.
Intervention: Ten sessions of intervention with conventional physiotherapy program followed, by self-initiated sit-to-stand training with assistive device, or by manual sit-to-stand training.
Main outcome measure: Number of patients regained the independence of sit-to-stand, Sit-to-stand test from the balance master® and Five-repetitions sit-to-stand test.
Results: 69 patients (intervention n=36; control n=33) were randomized (mean age 69.8 (SD, 10.6), mean post stroke days 18.6 (SD 16.0)) for intention to treat analysis. 17 patients were excluded because of dropout before 10 sessions of training, leaving 52 (n=26; n=26) patients for per protocol analysis. 18 patients in intervention group and 10 patients in control group had regained the independence of sit-to-stand (Phil and Cramer's V: -0.31 and 0.31). The patients in intervention group were faster to complete the Five-repetition sit-to-stand test than the control group (32.7 secs (SD, 1.93) v 48.4 secs (SD, 6.8); 95% confidence interval, -30.8 to -0.7; p<0.05). No adverse side effects occurred during and after the training across groups.
Conclusions: Self-initiated sit-to-stand training by assistive device can help more stroke patients regain the independence of sit-to-stand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Mechanical assisted sit-to-stand training groupThe sit-to-stand training is assisted by mechanical device |
| Control group | Active comparator | Other: Manual assisted sit-to-stand training groupThe sit-to-stand training is assisted by manual device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- first episode of unilateral stroke with hemiparesis,
- able to understand and follow simple verbal instructions,
- able to sit unsupported for at least two minutes
- require lifting assistance to stand up from a 18 inches high plinth
Key exclusion criteria (3 listed)
- severe pain in the lower extremities when weight bearing or performing movement
- any other acute comorbid diseases such as unstable angina, recent myocardial infarction
- unstable medical / psychological condition
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 |
|---|---|---|
| Mechanical assisted sit-to-stand training groupAlso: sit-to-stand trainerMechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions | Device | Intervention group |
| Manual assisted sit-to-stand training groupAlso: physiotherapist assistedManual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions | Other | Control group |
Primary outcome
Number of patients regained the independence of sit-to-stand
Time frame: After 10 sessions of training
To compare how many patients can regain the independence of sit-to-stand between groups
Sit-to-Stand Test (SST) from the Balance Master®
Time frame: After 10 sessions of training
To assess the quality of sit-to-stand of patient
Five-Repetition Sit-to-Stand Test
Time frame: After 10 sessions of training
To assess the functional strength of lower limb, balance and transition move of patient
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 6 Sep 2018.
- 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.
Ng Chee Man, Joey, Master principal investigator
Tai Po Hospital
Woo Ka Ho, Marc, Master study director
Prince of Wales Hospital, Shatin, Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical assisted sit-to-stand training group and Manual assisted sit-to-stand training group in people with Stroke, run by Tai Po Hospital.
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 4 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: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients regained the independence of sit-to-stand (time frame: After 10 sessions of training). The study lists 3 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 6 Sep 2018.