Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke
Primary Purpose
Cerebrovascular Accident, Balance Impairment
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
trunk exercise on unstable exercise
Upper limb range of motion exercise
Sponsored by

About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring stroke, balance, Trunk exercise, Trunk control, standing
Eligibility Criteria
Inclusion Criteria:
- age: between 20-80 years old
- first time stroke
- could sit without back support at least 20 seconds
- could understand and follow experimental instructions
Exclusion Criteria:
- medically unstable
- other neuromuscular/musculoskeletal problems that would affect balance
Sites / Locations
- National Cheng Kung University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
trunk exercise on unstable surface
upper limb range of motion exercise
Arm Description
trunk exercise training in supine and sitting positions, with unstable surfaces
upper limb range of motion exercise in sitting with back fully supported
Outcomes
Primary Outcome Measures
Center of pressure
range of displacement (cm)
Angular velocity of the non-affected arm raising
mean velocity
Secondary Outcome Measures
Trunk Impairment Scale
total score (0-23); higher scores mean better outcome
6-meter walking tests
time (sec) to walk 6 meters
Full Information
NCT ID
NCT04434443
First Posted
June 11, 2020
Last Updated
June 15, 2020
Sponsor
National Cheng Kung University
Collaborators
Tainan Hospital, Ministry of Health and Welfare
1. Study Identification
Unique Protocol Identification Number
NCT04434443
Brief Title
Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke
Official Title
Effects of Trunk Exercise on Unstable Surface on Trunk Control and Balance in Persons With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
October 6, 2019 (Actual)
Study Completion Date
October 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
Collaborators
Tainan Hospital, Ministry of Health and Welfare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examined the effects of trunk exercise on unstable surfaces on trunk control and balance for persons in the sub-acute stage of stroke. The hypothesis was that, compared to upper limb exercises in well supported sitting position, this exercise would lead to better trunk control and sitting and standing balance. The results supported the hypothesis.
Detailed Description
Inpatients in the sub-acute stage of stroke were randomly assigned to receive upper limb range of motion exercises in well supported sitting position or trunk exercises on unstable surfaces in supine and sitting, 30 min per session, 2 sessions per week for 6 weeks, in addition to their daily conventional stroke rehabilitation. Sensorimotor functions, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale, and clinical outcome assessments, including Trunk Impairment Scale and 6-meter walk test, were conducted by a blinded assessor. Biomechanical outcome measures included center of pressure area while maintaining static posture and peak displacement while leaning forward, and the average speed of the unaffected arm raising (to represent the ability to provide a stable foundation for focal movement). These measures were taken in sitting without foot support, sitting with foot support and standing to reflect trunk control, sitting balance and standing balance, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Balance Impairment
Keywords
stroke, balance, Trunk exercise, Trunk control, standing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor not aware of group assignment
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trunk exercise on unstable surface
Arm Type
Experimental
Arm Description
trunk exercise training in supine and sitting positions, with unstable surfaces
Arm Title
upper limb range of motion exercise
Arm Type
Sham Comparator
Arm Description
upper limb range of motion exercise in sitting with back fully supported
Intervention Type
Other
Intervention Name(s)
trunk exercise on unstable exercise
Intervention Description
Participants would receive exercises on unstable surface. Started from supine position, participants had abdominal drawer-in maneuver with soft foam under the pelvic. Lower trunk rotation, bridging and abdominal muscles isometric contraction exercises were also used in this exercise during supine position, with different unstable surfaces used. Including soft foam under the feet, then progressed to BOSU ball under the feet, then progressed to the a BOSU ball under the feet combined with pelvic on soft foam. During sitting, BOSU ball and Swiss ball were used as unstable surface. Pelvic anterior-posterior tilt, lateral tilting, rotation, lifting, and stepping with arm swing were used in this position.
Intervention Type
Other
Intervention Name(s)
Upper limb range of motion exercise
Intervention Description
Upper limb range of motion exercise with trunk fully supported
Primary Outcome Measure Information:
Title
Center of pressure
Description
range of displacement (cm)
Time Frame
6 weeks
Title
Angular velocity of the non-affected arm raising
Description
mean velocity
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Trunk Impairment Scale
Description
total score (0-23); higher scores mean better outcome
Time Frame
6 weeks
Title
6-meter walking tests
Description
time (sec) to walk 6 meters
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age: between 20-80 years old
first time stroke
could sit without back support at least 20 seconds
could understand and follow experimental instructions
Exclusion Criteria:
medically unstable
other neuromuscular/musculoskeletal problems that would affect balance
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
12. IPD Sharing Statement
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Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke
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