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Evaluation and Rehabilitation for Coordinated Control of Bilateral Ankle Joints in Stroke Patients

T

Taipei Medical University

Status

Unknown

Conditions

Stroke,Rehabilitation,Coordination,Ankle

Treatments

Device: Bilateral ankle coordination training

Study type

Interventional

Funder types

Other

Identifiers

NCT05026359
N201904034

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Bilateral ankle coordination training group
Experimental group
Description:
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)
Treatment:
Device: Bilateral ankle coordination training
General rehabilitation intervention group
No Intervention group
Description:
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)

Trial contacts and locations

2

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Central trial contact

Chueh-Ho Lin Lin, PhD

Data sourced from clinicaltrials.gov

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