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

Primary Purpose

Stroke,Rehabilitation,Coordination,Ankle

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bilateral ankle coordination training
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke,Rehabilitation,Coordination,Ankle

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chang Jia LanRecruiting
  • Taipei Medical University Shuang Ho HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bilateral ankle coordination training group

General rehabilitation intervention group

Arm 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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 22, 2021
Last Updated
August 26, 2021
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05026359
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke,Rehabilitation,Coordination,Ankle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilateral ankle coordination training group
Arm Type
Experimental
Arm 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)
Arm Title
General rehabilitation intervention group
Arm Type
No Intervention
Arm 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)
Intervention Type
Device
Intervention Name(s)
Bilateral ankle coordination training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bilateral ankle coordination evaluation
Description
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.
Time Frame
Change from Baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Lower Extremity motor control of Fugl-Meyer Assessment (FMA-LE)
Description
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.
Time Frame
Change from Baseline at 4 weeks
Title
Gait kinematics evaluation
Description
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.
Time Frame
Change from Baseline at 4 weeks
Title
Berg Balance Test (BBS)
Description
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.
Time Frame
Change from Baseline at 4 weeks
Title
Time Up and Go Test (Time Up and Go, TUG)
Description
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.
Time Frame
Change from Baseline at 4 weeks
Title
Barthel Index (BI)
Description
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.
Time Frame
Change from Baseline at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 no other orthopedic or neurological disorders Brunnstrom stage 4 no participation in other experimental rehabilitation or drug studies Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chueh-Ho Lin Lin, PhD
Phone
+88627361661
Ext
6325
Email
chueh.ho@tmu.edu.tw
Facility Information:
Facility Name
Chang Jia Lan
City
New Taipei City
State/Province
Shuang Ho Hospital
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHANG JIALAN, master
Phone
+88622490088
Ext
1608
Email
08173@s.tmu.edu.tw
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHANG JIA LAN, master
Phone
+88622490088
Ext
1608
Email
08173@s.tmu.edu.tw

12. IPD Sharing Statement

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

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