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

Stroke Clinical Trial

Official title:

Effects of Sit-to-stand Training With Interactive Feedback on Muscle Contraction Sequences and Weight Bearing Symmetry in Individuals With Chronic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05945134
• Other study ID #: NYCU112081AE
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: National Yang Ming University
• Contact: Ray-Yau Wang, PhD
• Phone: +886-2-28267210
• Email: rywang[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Visual and auditory feedback STS training
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.
• Conventional STS training
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.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	5 minutes, Change from baseline onset time at 3-week post-test
Primary	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)	5 minutes, Change from baseline peak force time at 3-week post-test
Primary	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)	5 minutes, Change from baseline offset time at 3-week post-test
Primary	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|	5 minutes, Change from baseline weight bearing symmetry at 3-week post-test
Primary	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	5 minutes, Change from baseline COP sway pathway at 3-week post-test
Secondary	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"	5 minutes, Change from baseline sit to stand duration at 3-week post-test
Secondary	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|	5 minutes, Change from baseline symmetry of gait speed at 3-week post-test
Secondary	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|	5 minutes, Change from baseline symmetry of step length at 3-week post-test
Secondary	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|	5 minutes, Change from baseline symmetry of step time at 3-week post-test