Stroke，Rehabilitation，Coordination，AnkleNCT05026359
Evaluation and Rehabilitation for Coordinated Control of Bilateral Ankle Joints in Stroke Patients
A study testing Bilateral ankle coordination training in people with Stroke，Rehabilitation，Coordination，Ankle, run by Taipei Medical University Shuang Ho Hospital at 2 sites in Taiwan.
Trial summary
The coordinated control between the bilateral ankles plays an important role in daily life functions such as walking and balance. The central nervous system damage caused by stroke, in addition to the limitation of the ankle movement on the hemiplegic side and the deterioration of the movement ability, It will… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke，Rehabilitation，Coordination，Ankle
- What is being tested?
- Bilateral ankle coordination training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 14 Aug 2019to 30 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 6 months since stroke
- three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history
- ability to follow the researcher's instructions
- the ability to flex and extend the paretic lower limb and ankle
- Modified Ashworth Score (MAS) ≦3 for the ankle joints
- a Mini-Mental State Examination (MMSE) score of 24 or higher
Show all 9Show fewer
- no other orthopedic or neurological disorders
- Brunnstrom stage 4
- no participation in other experimental rehabilitation or drug studies
Who cannot join
- unstable cardiovascular conditions
- uncontrolled hypertension (190/110 mm Hg)
- severe orthopedic or pain conditions
- dementia (Mini-Mental State Examination score < 22)
- aphasia with inability to follow researcher's commands
- Visual dysfunction
- severe joint contracture of bilateral lower limb extremities that would impact the movement performance of the lower limb extremities
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Chang Jia Lan
New Taipei City, Shuang Ho Hospital, 235
CHANG JIALAN, master, +88622490088 ext. 1608, 08173@s.tmu.edu.tw
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City
CHANG JIA LAN, master, +88622490088 ext. 1608, 08173@s.tmu.edu.tw
About this study
Official title: Effects of Interlimb Coordination Coupling Training on Paretic Ankle and Lower Limb Motor Recovery Following Chronic Stroke
The coordinated control between the bilateral ankles plays an important role in daily life functions such as walking and balance. The central nervous system damage caused by stroke, in addition to the limitation of the ankle movement on the hemiplegic side and the deterioration of the movement ability, It will seriously affect the coordinated control performance between the bilateral ankle joints, which will cause the majority of stroke patients to have barriers to walking function, and increase the patient's daily care depending on the caregiver. However, there is currently no research on stroke patients, the development of a coordinated control evaluation method with bilateral ankle joints, the use of load-bearing state simulation similar to the real-life bilateral ankle and foot coordination control performance, the establishment of clinical value of bilateral ankle Coordinating the performance parameters of the control evaluation; thus, the clinical doctors can not accurately understand the degree of defect in the bilateral foot and ankle coordination control of the stroke patients, and explore the influence of the bilateral ankle-foot coordination control defect on the daily life function of the stroke patients, and even cannot be based on the evaluation results. The clinical parameters, combined with visual feedback and bilateral rehabilitation advantages of rehabilitation training program, improve the bilateral ankle joint coordination control ability and lower limb function of stroke patients. Therefore, the purpose of this study is to establish an assessment system that can be used to measure the performance of bilateral ankle joint coordination control, to understand the degree of injury in bilateral ankle and foot coordination control, and to analyze the biped coordination parameters and clinical gait performance. The characteristics, and then the design of a double-sided rehabilitation training program combined with visual feedback, is used to improve the bilateral ankle joint coordination control performance and lower limb movement function of stroke patients.
- Conditions
- Stroke，Rehabilitation，Coordination，Ankle
- Being tested
- Bilateral ankle coordination training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral ankle coordination trainingDevice
Developed a novel bilateral ankle coordination training program with visual feedback and bilateral ankle control, based on the concept of bilateral movement therapy. The bilateral ankle coordination training includes 3 days a week, 30 minutes each time, lasting 4 weeks, and a total of 12 training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral ankle coordination training group | Experimental | Exercise training of bilateral ankle coordination training group consisted of 30 minutes of bilateral ankle coordination training 3 days per week for 4 weeks (total 12 sessions) Receives: Device: Bilateral ankle coordination training |
| General rehabilitation intervention group | No intervention | Exercise training of walking and balance training consisted of 30 minutes of general rehabilitation intervention group 3 days per week for 4 weeks (total 12 sessions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral ankle coordination evaluation
The foot (affected foot) first moves to 10° plantar flexion, and the other foot moves to 10° dorsiflexion for 10 seconds; then one foot gradually moves from 10° plantar flexion to 10° dorsiflexion, and the other foot moves from dorsiflexion 10° °Move to 10° plantar flexion.The "alternating time" and "alternating angle" values for coordination of bilateral ankles were calculated. To enable comparison of the alternating time and alternating angle applied for each subject, the data units were normalized as a percentage. We calculated the coefficient of variation (CV) values for the "alternating time" and "alternating angle"from the non-dominant (non-paretic) ankle to the dominant (paretic) ankle. This revealed the overall variation in alternating time and alternating angle on the coordination control of individuals in this study.
Measured: Change from Baseline at 4 weeks
Secondary outcomes (5)
Lower Extremity motor control of Fugl-Meyer Assessment (FMA-LE)
most widely used assessment of paretic limb motor impairment for persons with stroke.Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total scale score is 34.
Measured: Change from Baseline at 4 weeks
Gait kinematics evaluation
The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait function.
Measured: Change from Baseline at 4 weeks
Berg Balance Test (BBS)
A representative method for assessing the balance ability of stroke patients. Patients receive a score from 0-4 on their ability to meet these balance dimensions. A global score can be calculated out of 56. A score of 0 represents an inability to complete the item, and a score of 56 represents the ability to independently complete the item.
Measured: Change from Baseline at 4 weeks
Time Up and Go Test (Time Up and Go, TUG)
To determine fall risk and measure the progress of balance, sit to stand and walking.The individual must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down. The score consists of the time taken to complete the test activity, in seconds and ≥12 seconds to complete the TUG is at risk for falling.
Measured: Change from Baseline at 4 weeks
Barthel Index (BI)
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. Total score ranges from 0-100.
Measured: Change from Baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start14 Aug 2019
- Primary completion1 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke，Rehabilitation，Coordination，AnkleStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026359
- Sponsor's protocol ID
- N201904034
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interlimb Coordination Coupling Training on Paretic Ankle and Lower Limb Motor Recovery Following Chronic Stroke
- ClinicalTrials.gov ID
- NCT05026359
- Acronym / sponsor ID
- N201904034
- Conditions
- Stroke，Rehabilitation，Coordination，Ankle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 30 Aug 2021 (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 coordinated control between the bilateral ankles plays an important role in daily life functions such as walking and balance. The central nervous system damage caused by stroke, in addition to the limitation of the ankle movement on the hemiplegic side and the deterioration of the movement ability, It will seriously affect the coordinated control performance between the bilateral ankle joints, which will cause the majority of stroke patients to have barriers to walking function, and increase the patient's daily care depending on the caregiver. However, there is currently no research on stroke patients, the development of a coordinated control evaluation method with bilateral ankle joints, the use of load-bearing state simulation similar to the real-life bilateral ankle and foot coordination control performance, the establishment of clinical value of bilateral ankle Coordinating the performance parameters of the control evaluation; thus, the clinical doctors can not accurately understand the degree of defect in the bilateral foot and ankle coordination control of the stroke patients, and explore the influence of the bilateral ankle-foot coordination control defect on the daily life function of the stroke patients, and even cannot be based on the evaluation results. The clinical parameters, combined with visual feedback and bilateral rehabilitation advantages of rehabilitation training program, improve the bilateral ankle joint coordination control ability and lower limb function of stroke patients. Therefore, the purpose of this study is to establish an assessment system that can be used to measure the performance of bilateral ankle joint coordination control, to understand the degree of injury in bilateral ankle and foot coordination control, and to analyze the biped coordination parameters and clinical gait performance. The characteristics, and then the design of a double-sided rehabilitation training program combined with visual feedback, is used to improve the bilateral ankle joint coordination control performance and lower limb movement function of stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral ankle coordination training group | Experimental | Device: Bilateral ankle coordination trainingExercise training of bilateral ankle coordination training group consisted of 30 minutes of bilateral ankle coordination training 3 days per week for 4 weeks (total 12 sessions) |
| General rehabilitation intervention group | No intervention | –Exercise training of walking and balance training consisted of 30 minutes of general rehabilitation intervention group 3 days per week for 4 weeks (total 12 sessions) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- at least 6 months since stroke
- three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history
- ability to follow the researcher's instructions
- the ability to flex and extend the paretic lower limb and ankle
- Modified Ashworth Score (MAS) ≦3 for the ankle joints
Key exclusion criteria (7 listed)
- unstable cardiovascular conditions
- uncontrolled hypertension (190/110 mm Hg)
- severe orthopedic or pain conditions
- dementia (Mini-Mental State Examination score < 22)
- aphasia with inability to follow researcher's commands
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 |
|---|---|---|
| Bilateral ankle coordination trainingDeveloped a novel bilateral ankle coordination training program with visual feedback and bilateral ankle control, based on the concept of bilateral movement therapy. The bilateral ankle coordination training includes 3 days a week, 30 minutes each time, lasting 4 weeks, and a total of 12 training sessions. | Device | Bilateral ankle coordination training group |
Primary outcome
Bilateral ankle coordination evaluation
Time frame: Change from Baseline at 4 weeks
The foot (affected foot) first moves to 10° plantar flexion, and the other foot moves to 10° dorsiflexion for 10 seconds; then one foot gradually moves from 10° plantar flexion to 10° dorsiflexion, and the other foot moves from dorsiflexion 10° °Move to 10° plantar flexion.The "alternating time" and "alternating angle" values for coordination of bilateral ankles were calculated. To enable comparison of the alternating time and alternating angle applied for each subject, the data units were normalized as a percentage. We calculated the coefficient of variation (CV) values for the "alternating time" and "alternating angle"from the non-dominant (non-paretic) ankle to the dominant (paretic) ankle. This revealed the overall variation in alternating time and alternating angle on the coordination control of individuals in this study.
5 secondary outcomes
Lower Extremity motor control of Fugl-Meyer Assessment (FMA-LE)
Time frame: Change from Baseline at 4 weeks
Gait kinematics evaluation
Time frame: Change from Baseline at 4 weeks
Berg Balance Test (BBS)
Time frame: Change from Baseline at 4 weeks
Time Up and Go Test (Time Up and Go, TUG)
Time frame: Change from Baseline at 4 weeks
Barthel Index (BI)
Time frame: Change from Baseline at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral ankle coordination training in people with Stroke，Rehabilitation，Coordination，Ankle, run by Taipei Medical University Shuang Ho Hospital at 2 sites 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 9 inclusion and 7 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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chueh-Ho Lin Lin, PhD (+88627361661 ext. 6325, chueh.ho@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral ankle coordination evaluation (time frame: Change from Baseline at 4 weeks). 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 30 Aug 2021.