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Turning Dysfunction After Stroke: Assessment and Intervention

Primary Purpose

Stroke, Walking, Difficulty, Balancing Interference

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Trunk exercise
Sponsored by
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age between 20 and 80 years old survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study able to walk independently over a distance of 10 m without walking aids or orthoses able to provide informed consent and follow instructions. Exclusion Criteria: having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.

Sites / Locations

  • Taipei Tzu Chi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Trunk exercise group

Control group

Arm Description

Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.

Participants remained their regular activities.

Outcomes

Primary Outcome Measures

Change from Baseline in turning duration at Week 12
Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Longer duration represents poorer turning performance.
Change from Baseline in turning angular velocity at Week 12
Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Slower angular velocity represents instability during turning.
Change from Baseline in trunk muscles electromyography during turning at Week 12
Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis. Greater muscle amplitude represents greater muscle contraction.

Secondary Outcome Measures

Change from Baseline in trunk range of motion at Week 12
The trunk range of motion (ROM) was measured using a tape measure in sitting position. The spinous processes at C7 and S1 served as landmarks for placement of the tape and measurement for trunk flexion and extension ROM. The length between iliac crest and contralateral acromion of scapula was measured for trunk rotation ROM while the distance between the tip of the middle finger and the floor for trunk lateral flexion ROM. The difference between tape measures in starting and ending positions was calculated for all trunk movement directions. Greater value of trunk flexion and rotation but smaller value of trunk extension and lateral flexion represents better trunk ROM.
Change from Baseline in trunk muscles strength at Week 12
Trunk flexors, extensors, rotators, and lateral flexors strength were measured using a MicroFET3 dynamometer. Participants were asked to generate the maximum trunk flexion, extension, rotation bilaterally and lateral flexion bilaterally for a period of 6 seconds each. Resistance was applied using the dynamometer to obtain the value of each trunk muscle (kg). Greater value represents greater muscle strength.
Change from Baseline in Trunk Impairment Scale at Week 12
Trunk control was assessed by the Trunk Impairment Scale (TIS) which has good inter-rater reliability with intra-class coefficient 0.85-0.99 and internal consistency with Cronbach's α 0.65-0.89. The TIS evaluates static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.

Full Information

First Posted
December 8, 2020
Last Updated
December 13, 2020
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborators
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04668573
Brief Title
Turning Dysfunction After Stroke: Assessment and Intervention
Official Title
Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborators
Taipei Medical University

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 study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.
Detailed Description
This study has two parts. The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). The second part is a randomized controlled trial. Stroke participants are randomly allocated into trunk exercise and control groups. Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. Turning performance, trunk control and motor function are evaluated before and after training session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Walking, Difficulty, Balancing Interference

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trunk exercise group
Arm Type
Experimental
Arm Description
Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants remained their regular activities.
Intervention Type
Other
Intervention Name(s)
Trunk exercise
Intervention Description
Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline in turning duration at Week 12
Description
Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Longer duration represents poorer turning performance.
Time Frame
Baseline and Week 12
Title
Change from Baseline in turning angular velocity at Week 12
Description
Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Slower angular velocity represents instability during turning.
Time Frame
Baseline and Week 12
Title
Change from Baseline in trunk muscles electromyography during turning at Week 12
Description
Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis. Greater muscle amplitude represents greater muscle contraction.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in trunk range of motion at Week 12
Description
The trunk range of motion (ROM) was measured using a tape measure in sitting position. The spinous processes at C7 and S1 served as landmarks for placement of the tape and measurement for trunk flexion and extension ROM. The length between iliac crest and contralateral acromion of scapula was measured for trunk rotation ROM while the distance between the tip of the middle finger and the floor for trunk lateral flexion ROM. The difference between tape measures in starting and ending positions was calculated for all trunk movement directions. Greater value of trunk flexion and rotation but smaller value of trunk extension and lateral flexion represents better trunk ROM.
Time Frame
Baseline and Week 12
Title
Change from Baseline in trunk muscles strength at Week 12
Description
Trunk flexors, extensors, rotators, and lateral flexors strength were measured using a MicroFET3 dynamometer. Participants were asked to generate the maximum trunk flexion, extension, rotation bilaterally and lateral flexion bilaterally for a period of 6 seconds each. Resistance was applied using the dynamometer to obtain the value of each trunk muscle (kg). Greater value represents greater muscle strength.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Trunk Impairment Scale at Week 12
Description
Trunk control was assessed by the Trunk Impairment Scale (TIS) which has good inter-rater reliability with intra-class coefficient 0.85-0.99 and internal consistency with Cronbach's α 0.65-0.89. The TIS evaluates static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
Time Frame
Baseline and Week 12
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Modified Clinical Test of Sensory Integration and Balance at Week 12
Description
Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised. The postural sway was measured in 4 sensory conditions through visual and proprioceptive manipulation using APDM Opal wireless sensors. The greater postural sway represents the poorer balance.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Berg Balance Scale at Week 12
Description
The Berg balance scale (BBS) is used to objectively determine a participant's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. The total score is 56.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Timed Up and Go test at Week 12
Description
Function mobility was assessed by the Timed Up and Go (TUG) test. Participants were instructed to stand up from a chair, walk 3 meters, turn around, and walk back to the chair sit down. Time to complete the task was recorded. The more time taken is representative of the lower level of functional mobility.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 20 and 80 years old survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study able to walk independently over a distance of 10 m without walking aids or orthoses able to provide informed consent and follow instructions. Exclusion Criteria: having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Jung Liang
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Tzu Chi Hospital
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Turning Dysfunction After Stroke: Assessment and Intervention

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