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Sit-to-stand Training With Interactive Feedback in Chronic Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Visual and auditory feedback STS training
Conventional STS training
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Interactive feedback, Muscle contraction sequence, Weight bearing symmetry, Sit-to-stand training, Chronic stroke

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of stroke ≥ 6 months Mini-mental state examination (MMSE) ≥ 24 points Brunnstrom lower limb recovery stage: ≥ stage 3 Be able to independently perform STS for at least 10 times Single STS >1.7 seconds Be able to walk ≥10 meters independently Exclusion Criteria: Any other musculoskeletal, neurological and cardiovascular diseases Have visual or language impairments

Sites / Locations

  • National Yang Ming Chiao Tung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Visual and auditory feedback STS training group

Conventional STS training group

Arm Description

The interactive interface of visual and auditory feedback system was designed using LabVIEW and integrated force plates for training. Signals from the pressure detectors of the seat and two force plates on the floor will be converted to the indication of the body weight distribution (indicated by the size of the two circles of both legs, larger circle represented the more weight beard on the leg) and the movement path of the overall center of pressure (indicated by a mobile solid dot).

Only verbal and visual cues which were commonly used by the therapist.

Outcomes

Primary Outcome Measures

Sit to stand performance: change in onset time of muscle contraction sequences
Use the surface electromyography to evaluate the "onset" time (% MT, EMG activities ≥ 2 SD of the baseline for ≥100 ms) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Sit to stand performance: change in peak force time of muscle contraction sequences
Use the surface electromyography to evaluate the "peak force" time (% MT, maximal EMG activities) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Sit to stand performance: change in offset time of muscle contraction sequences
Use the surface electromyography to evaluate the "offset" time (% MT, EMG activities < 2 SD of the baseline for ≥100 ms) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Sit to stand performance: change in weight bearing symmetry
Use the force plates to evaluate the "cumulative vertical force " (% of body weight), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Sit to stand performance: change in COP sway pathway
Use the force plates to evaluate the total length (cm) of the moving pathway of the overall center of pressure in X or Y axis individually

Secondary Outcome Measures

Sit to stand performance: change in sit to stand duration
Use the surface electromyography to evaluate the "movement time" (MT, sec), using the "offset time of the last activated muscle" - "onset time of the first activated muscle"
Gait performance: change in symmetry of gait speed
Use the GAITRite® system to evaluate gait speed (m/s) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Gait performance: change in symmetry of step length
Use the GAITRite® system to evaluate step length (m) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Gait performance: change in symmetry of step time
Use the GAITRite® system to evaluate step time (sec) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|

Full Information

First Posted
July 3, 2023
Last Updated
July 16, 2023
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05945134
Brief Title
Sit-to-stand Training With Interactive Feedback in Chronic Stroke
Official Title
Effects of Sit-to-stand Training With Interactive Feedback on Muscle Contraction Sequences and Weight Bearing Symmetry in Individuals With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

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

5. Study Description

Brief Summary
The major problems of people with chronic stroke include muscle weakness, sensory alteration, and inter-muscular coordination impairment. Inter-muscular coordination impairment caused altered muscle contraction sequences and weight-bearing asymmetry during functional activities. Sit-to-stand (STS) training is often used to improve functional activities among post-stroke subjects. However, the improvement may come from compensatory movements. Using compensatory movement may cause muscle weakness in the affected side and increase fall risk. This study will develop a novel STS training system with interactive visual and audio feedback emphasizing weight transferring and weight bearing. The present study aims to investigate the effects of sit-to-stand training with interactive visual and audio feedback on muscle contraction sequences and weight bearing symmetry in individuals with chronic stroke.
Detailed Description
This is a prospective randomized single-blinded controlled trial with pre- and post-measurements. 20 individuals will be recruited, and randomly assigned to experimental or control group. Statistical data analysis will be done by SPSS 24.0. Baseline characteristics will be analyzed using independent t-test or Chi-square test. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used for time-by-group comparisons. The significant level is set at 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Interactive feedback, Muscle contraction sequence, Weight bearing symmetry, Sit-to-stand training, Chronic stroke

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Visual and auditory feedback STS training group
Arm Type
Experimental
Arm Description
The interactive interface of visual and auditory feedback system was designed using LabVIEW and integrated force plates for training. Signals from the pressure detectors of the seat and two force plates on the floor will be converted to the indication of the body weight distribution (indicated by the size of the two circles of both legs, larger circle represented the more weight beard on the leg) and the movement path of the overall center of pressure (indicated by a mobile solid dot).
Arm Title
Conventional STS training group
Arm Type
Active Comparator
Arm Description
Only verbal and visual cues which were commonly used by the therapist.
Intervention Type
Other
Intervention Name(s)
Visual and auditory feedback STS training
Intervention Description
30 minutes per session, 3 sessions per week, for a total of 3 weeks. The visual and auditory feedback signals will be given throughout the sit-to-stand movement. As the size of circle representing the weight bearing gets more even, and the mobile dot indicating the overall center of pressure moves forward and approaches the midline, the auditory cues will get louder to indicate proximity to the target. It allows the participants to adjust and relearn the correct weight shifting and symmetry. The intensity will be adjusted based on different chair heights (e.g. 115%, 100%, 80% of lower leg length), various seat materials, and supported level of thigh (progressing from one-third of the length between the greater trochanter of the femur and the knee joint line to full support). The training program will be progressed according to the abilities of the participants.
Intervention Type
Other
Intervention Name(s)
Conventional STS training
Intervention Description
30 minutes per session, 3 sessions per week, for a total of 3 weeks. All settings will be the same as the experimental group, except for the feedback. In the control group, the verbal cues will be given by the physical therapist and a mirror will be placed in front of the participant for visual feedback. During the sit-to-stand movement, participants will be asked to try to maintain the alignment in the midline.
Primary Outcome Measure Information:
Title
Sit to stand performance: change in onset time of muscle contraction sequences
Description
Use the surface electromyography to evaluate the "onset" time (% MT, EMG activities ≥ 2 SD of the baseline for ≥100 ms) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Time Frame
5 minutes, Change from baseline onset time at 3-week post-test
Title
Sit to stand performance: change in peak force time of muscle contraction sequences
Description
Use the surface electromyography to evaluate the "peak force" time (% MT, maximal EMG activities) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Time Frame
5 minutes, Change from baseline peak force time at 3-week post-test
Title
Sit to stand performance: change in offset time of muscle contraction sequences
Description
Use the surface electromyography to evaluate the "offset" time (% MT, EMG activities < 2 SD of the baseline for ≥100 ms) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Time Frame
5 minutes, Change from baseline offset time at 3-week post-test
Title
Sit to stand performance: change in weight bearing symmetry
Description
Use the force plates to evaluate the "cumulative vertical force " (% of body weight), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Time Frame
5 minutes, Change from baseline weight bearing symmetry at 3-week post-test
Title
Sit to stand performance: change in COP sway pathway
Description
Use the force plates to evaluate the total length (cm) of the moving pathway of the overall center of pressure in X or Y axis individually
Time Frame
5 minutes, Change from baseline COP sway pathway at 3-week post-test
Secondary Outcome Measure Information:
Title
Sit to stand performance: change in sit to stand duration
Description
Use the surface electromyography to evaluate the "movement time" (MT, sec), using the "offset time of the last activated muscle" - "onset time of the first activated muscle"
Time Frame
5 minutes, Change from baseline sit to stand duration at 3-week post-test
Title
Gait performance: change in symmetry of gait speed
Description
Use the GAITRite® system to evaluate gait speed (m/s) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Time Frame
5 minutes, Change from baseline symmetry of gait speed at 3-week post-test
Title
Gait performance: change in symmetry of step length
Description
Use the GAITRite® system to evaluate step length (m) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Time Frame
5 minutes, Change from baseline symmetry of step length at 3-week post-test
Title
Gait performance: change in symmetry of step time
Description
Use the GAITRite® system to evaluate step time (sec) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Time Frame
5 minutes, Change from baseline symmetry of step time at 3-week post-test

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: Diagnosis of stroke ≥ 6 months Mini-mental state examination (MMSE) ≥ 24 points Brunnstrom lower limb recovery stage: ≥ stage 3 Be able to independently perform STS for at least 10 times Single STS >1.7 seconds Be able to walk ≥10 meters independently Exclusion Criteria: Any other musculoskeletal, neurological and cardiovascular diseases Have visual or language impairments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ray-Yau Wang, PhD
Phone
+886-2-28267210
Email
rywang@nycu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Hua Lin, BS
Phone
+886-928111947
Email
j.ptat.lin.be11@nycu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang, PhD
Organizational Affiliation
rywang@nycu.edu.tw
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang, PhD
Phone
+886-2-28267210
Email
rywang@nycu.edu.tw

12. IPD Sharing Statement

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Sit-to-stand Training With Interactive Feedback in Chronic Stroke

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