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

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT05945134
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-14
• Study Start: 2023-07-15
• Last Update Submitted: 2023-07-16
• Last Update Posted: 2023-07-18
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sit to stand performance: change in onset time of muscle contraction sequences	5 minutes, Change from baseline onset time at 3-week post-test	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	5 minutes, Change from baseline peak force time at 3-week post-test	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	5 minutes, Change from baseline offset time at 3-week post-test	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 COP sway pathway	5 minutes, Change from baseline COP sway pathway at 3-week post-test	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
Sit to stand performance: change in weight bearing symmetry	5 minutes, Change from baseline weight bearing symmetry at 3-week post-test	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\|

Secondary Outcome Measures

Name	Time	Method
Gait performance: change in symmetry of step time	5 minutes, Change from baseline symmetry of step time at 3-week post-test	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\|
Gait performance: change in symmetry of gait speed	5 minutes, Change from baseline symmetry of gait speed at 3-week post-test	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	5 minutes, Change from baseline symmetry of step length at 3-week post-test	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\|
Sit to stand performance: change in sit to stand duration	5 minutes, Change from baseline sit to stand duration at 3-week post-test	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"

Trial Locations

Locations (1)

National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan