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

Sponsor
National Yang Ming University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05945134
Collaborator
(none)
20
1
2
11.5
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Visual and auditory feedback STS training
  • Other: Conventional STS training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Sit-to-stand Training With Interactive Feedback on Muscle Contraction Sequences and Weight Bearing Symmetry in Individuals With Chronic Stroke
Anticipated Study Start Date :
Jul 15, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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)

  3. 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)

  4. 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|

  5. 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

Secondary Outcome Measures

  1. 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"

  2. 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|

  3. 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|

  4. 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|

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Yang Ming Chiao Tung University Taipei Taiwan 112

Sponsors and Collaborators

  • National Yang Ming University

Investigators

  • Principal Investigator: Ray-Yau Wang, PhD, rywang@nycu.edu.tw

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Yang Ming University
ClinicalTrials.gov Identifier:
NCT05945134
Other Study ID Numbers:
  • NYCU112081AE
First Posted:
Jul 14, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Yang Ming University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2023