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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Visual and auditory feedback STS training; Other: Conventional STS training

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ray-Yau Wang, PhD; Phone Number: +886-2-28267210; Email: rywang@nycu.edu.tw
• Study Contact Backup: Name: Hsin-Hua Lin, BS; Phone Number: +886-928111947; Email: j.ptat.lin.be11@nycu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • National Yang Ming Chiao Tung University
    • Contact: Ray-Yau Wang, PhD; Phone Number: +886-2-28267210; Email: rywang@nycu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual and auditory feedback STS training group; 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).	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.
Active Comparator: Conventional STS training group; Only verbal and visual cues which were commonly used by the therapist.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: Ray-Yau Wang, PhD, rywang@nycu.edu.tw

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chronic stroke; Interactive feedback; Muscle contraction sequence; Weight bearing symmetry; Sit-to-stand training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NYCU112081AE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No