Clinical trial NCT05026359: Evaluation and Rehabilitation for Coordinated Control of Bilateral Ankle Joints in Stroke Patients
Official title: Effects of Interlimb Coordination Coupling Training on Paretic Ankle and Lower Limb Motor Recovery Following Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke，Rehabilitation，Coordination，Ankle
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. at least 6 months since stroke
2. three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history
3. ability to follow the researcher's instructions
4. the ability to flex and extend the paretic lower limb and ankle
5. Modified Ashworth Score (MAS) ≦3 for the ankle joints
6. a Mini-Mental State Examination (MMSE) score of 24 or higher
7. no other orthopedic or neurological disorders
8. Brunnstrom stage 4
9. no participation in other experimental rehabilitation or drug studies

Exclusion Criteria:

1. unstable cardiovascular conditions
2. uncontrolled hypertension (190/110 mm Hg)
3. severe orthopedic or pain conditions
4. dementia (Mini-Mental State Examination score \< 22)
5. aphasia with inability to follow researcher's commands
6. Visual dysfunction
7. severe joint contracture of bilateral lower limb extremities that would impact the movement performance of the lower limb extremities

Primary outcomes:
measure: Bilateral ankle coordination evaluation
timeFrame: Change from Baseline at 4 weeks
Secondary outcomes:
measure: Lower Extremity motor control of Fugl-Meyer Assessment (FMA-LE)
timeFrame: Change from Baseline at 4 weeks
measure: Gait kinematics evaluation
timeFrame: Change from Baseline at 4 weeks
measure: Berg Balance Test (BBS)
timeFrame: Change from Baseline at 4 weeks
measure: Time Up and Go Test (Time Up and Go, TUG)
timeFrame: Change from Baseline at 4 weeks
measure: Barthel Index (BI)
timeFrame: Change from Baseline at 4 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Chang Jia Lan
state: Shuang Ho Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
References: