Clinical trial NCT04668573: Turning Dysfunction After Stroke: Assessment and Intervention
Official title: Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Walking, Difficulty
Balancing Interference
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
Collaborators: name: Taipei Medical University
First posted: 2020-12-16
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study has two parts. The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). The second part is a randomized controlled trial. Stroke participants are randomly allocated into trunk exercise and control groups. Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. Turning performance, trunk control and motor function are evaluated before and after training session.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in turning duration at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in turning angular velocity at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in trunk muscles electromyography during turning at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from Baseline in trunk range of motion at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in trunk muscles strength at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Trunk Impairment Scale at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
measure: Change from Baseline in Modified Clinical Test of Sensory Integration and Balance at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Berg Balance Scale at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Timed Up and Go test at Week 12
timeFrame: Baseline and Week 12
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Pei-Jung Liang
role: PRINCIPAL_INVESTIGATOR
References: