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

NCT05945134 | Unknown

• 1 other identifier: NYCU112081AE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Interactive feedback; Muscle contraction sequence; Weight bearing symmetry; Sit-to-stand training; Chronic stroke

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Sit to stand performance: change in sit to stand duration

  5 minutes, Change from baseline sit to stand duration at 3-week post-test

• Gait performance: change in symmetry of gait speed

  5 minutes, Change from baseline symmetry of gait speed at 3-week post-test

• Gait performance: change in symmetry of step length

  5 minutes, Change from baseline symmetry of step length at 3-week post-test

• Gait performance: change in symmetry of step time

  5 minutes, Change from baseline symmetry of step time at 3-week post-test

Study Arms (2)

Visual and auditory feedback STS training group

EXPERIMENTAL

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

Conventional STS training group

ACTIVE COMPARATOR

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

Other: Conventional STS training

Interventions

Visual and auditory feedback STS training OTHER

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.

Visual and auditory feedback STS training group

Conventional STS training OTHER

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.

Conventional STS training group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any other musculoskeletal, neurological and cardiovascular diseases
• Have visual or language impairments

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ray-Yau Wang, PhD

  rywang@nycu.edu.tw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray-Yau Wang, PhD

CONTACT

+886-2-28267210; rywang@nycu.edu.tw

Hsin-Hua Lin, BS

CONTACT

+886-928111947; j.ptat.lin.be11@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 14, 2023
• Study Start: July 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-06

Locations

TW (1)