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

NCT ID: NCT05026359

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-14
• Study Completion Date: 2021-11-30

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.

Conditions

Stroke，Rehabilitation，Coordination，Ankle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bilateral ankle coordination training group

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)

Group Type: EXPERIMENTAL

Bilateral ankle coordination training

Intervention Type: DEVICE

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.

General rehabilitation intervention group

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bilateral ankle coordination training

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Jia Lan

New Taipei City, Shuang Ho Hospital, Taiwan

Site Status: RECRUITING

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chueh-Ho Lin Lin, PhD

Role: CONTACT

chueh.ho@tmu.edu.tw

+88627361661 ext. 6325

Facility Contacts

CHANG JIALAN, master

Role: primary

08173@s.tmu.edu.tw

+88622490088 ext. 1608

CHANG JIA LAN, master

Role: primary

08173@s.tmu.edu.tw

+88622490088 ext. 1608

Other Identifiers

N201904034

Identifier Type: -

Identifier Source: org_study_id