Turning Dysfunction After Stroke: Assessment and Intervention

NCT04668573 | Completed

• 1 other identifier: 08-XD-051
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.

Conditions

Stroke; Walking, Difficulty; Balancing Interference

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in turning duration at Week 12

  Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Longer duration represents poorer turning performance.

  Baseline and Week 12

• Change from Baseline in turning angular velocity at Week 12

  Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Slower angular velocity represents instability during turning.

  Baseline and Week 12

• Change from Baseline in trunk muscles electromyography during turning at Week 12

  Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis. Greater muscle amplitude represents greater muscle contraction.

  Baseline and Week 12

Secondary Outcomes (3)

• Change from Baseline in trunk range of motion at Week 12

  Baseline and Week 12

• Change from Baseline in trunk muscles strength at Week 12

  Baseline and Week 12

• Change from Baseline in Trunk Impairment Scale at Week 12

  Baseline and Week 12

Other Outcomes (3)

• Change from Baseline in Modified Clinical Test of Sensory Integration and Balance at Week 12

  Baseline and Week 12

• Change from Baseline in Berg Balance Scale at Week 12

  Baseline and Week 12

• Change from Baseline in Timed Up and Go test at Week 12

  Baseline and Week 12

Study Arms (2)

Trunk exercise group

EXPERIMENTAL

Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.

Other: Trunk exercise

Control group

NO INTERVENTION

Participants remained their regular activities.

Interventions

Trunk exercise OTHER

Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.

Trunk exercise group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 20 and 80 years old
• survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
• able to walk independently over a distance of 10 m without walking aids or orthoses
• able to provide informed consent and follow instructions.

You may not qualify if:

• having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
• having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead
• Taipei Medical University: collaborator

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Stroke; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-Jung Liang

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: July 13, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)