StrokeNCT04668573
Turning Dysfunction After Stroke: Assessment and Intervention
A study testing Trunk exercise in people with Stroke and Walking, Difficulty, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Walking, Difficulty, Balancing Interference
- What is being tested?
- Trunk exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jul 2020to 31 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 20 and 80 years old
- survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
- able to walk independently over a distance of 10 m without walking aids or orthoses
- able to provide informed consent and follow instructions.
Who cannot join
- having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
- having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects
The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.
Read the detailed description
This study has two parts. The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). The second part is a randomized controlled trial. Stroke participants are randomly allocated into trunk exercise and control groups. Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. Turning performance, trunk control and motor function are evaluated before and after training session.
- Conditions
- Stroke, Walking, Difficulty, Balancing Interference
- Being tested
- Trunk exercise
- Medical subject headings
- Stroke, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk exerciseOther
Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Trunk exercise group | Experimental | Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks. Receives: Other: Trunk exercise |
| Control group | No intervention | Participants remained their regular activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in turning duration at Week 12
Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Longer duration represents poorer turning performance.
Measured: Baseline and Week 12
Change from Baseline in turning angular velocity at Week 12
Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Slower angular velocity represents instability during turning.
Measured: Baseline and Week 12
Change from Baseline in trunk muscles electromyography during turning at Week 12
Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis. Greater muscle amplitude represents greater muscle contraction.
Measured: Baseline and Week 12
Secondary outcomes (3)
Change from Baseline in trunk range of motion at Week 12
The trunk range of motion (ROM) was measured using a tape measure in sitting position. The spinous processes at C7 and S1 served as landmarks for placement of the tape and measurement for trunk flexion and extension ROM. The length between iliac crest and contralateral acromion of scapula was measured for trunk rotation ROM while the distance between the tip of the middle finger and the floor for trunk lateral flexion ROM. The difference between tape measures in starting and ending positions was calculated for all trunk movement directions. Greater value of trunk flexion and rotation but smaller value of trunk extension and lateral flexion represents better trunk ROM.
Measured: Baseline and Week 12
Change from Baseline in trunk muscles strength at Week 12
Trunk flexors, extensors, rotators, and lateral flexors strength were measured using a MicroFET3 dynamometer. Participants were asked to generate the maximum trunk flexion, extension, rotation bilaterally and lateral flexion bilaterally for a period of 6 seconds each. Resistance was applied using the dynamometer to obtain the value of each trunk muscle (kg). Greater value represents greater muscle strength.
Measured: Baseline and Week 12
Change from Baseline in Trunk Impairment Scale at Week 12
Trunk control was assessed by the Trunk Impairment Scale (TIS) which has good inter-rater reliability with intra-class coefficient 0.85-0.99 and internal consistency with Cronbach's α 0.65-0.89. The TIS evaluates static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start13 Jul 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University
- Responsible party
- Principal investigator, Pei Jung Liang, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Pei-Jung Liang, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668573
- Sponsor's protocol ID
- 08-XD-051
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- 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 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects
- ClinicalTrials.gov ID
- NCT04668573
- Acronym / sponsor ID
- 08-XD-051
- Conditions
- Stroke, Walking, Difficulty, Balancing Interference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Collaborators
- Taipei Medical University
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 16 Dec 2020 (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.
The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.
Detailed description
This study has two parts. The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). The second part is a randomized controlled trial. Stroke participants are randomly allocated into trunk exercise and control groups. Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. Turning performance, trunk control and motor function are evaluated before and after training session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trunk exercise group | Experimental | Other: Trunk exerciseParticipants received trunk exercise for 30 minutes per session, twice a week for 12 weeks. |
| Control group | No intervention | –Participants remained their regular activities. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 20 and 80 years old
- survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
- able to walk independently over a distance of 10 m without walking aids or orthoses
- able to provide informed consent and follow instructions.
Key exclusion criteria (2 listed)
- having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
- having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.
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 |
|---|---|---|
| Trunk exerciseTrunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks. | Other | Trunk exercise group |
Primary outcome
Change from Baseline in turning duration at Week 12
Time frame: Baseline and Week 12
Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Longer duration represents poorer turning performance.
Change from Baseline in turning angular velocity at Week 12
Time frame: Baseline and Week 12
Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Slower angular velocity represents instability during turning.
Change from Baseline in trunk muscles electromyography during turning at Week 12
Time frame: Baseline and Week 12
Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis. Greater muscle amplitude represents greater muscle contraction.
3 secondary outcomes
Change from Baseline in trunk range of motion at Week 12
Time frame: Baseline and Week 12
Change from Baseline in trunk muscles strength at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Trunk Impairment Scale at Week 12
Time frame: Baseline and Week 12
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 16 Dec 2020.
- 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.
Pei-Jung Liang principal investigator
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trunk exercise in people with Stroke and Walking, Difficulty, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 2 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 16 Dec 2020. 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 Taiwan. 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?
Change from Baseline in turning duration at Week 12 (time frame: Baseline and Week 12). 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 16 Dec 2020.