- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04434443
Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke
June 15, 2020 updated by: Sang-I Lin, National Cheng Kung University
Effects of Trunk Exercise on Unstable Surface on Trunk Control and Balance in Persons With Stroke
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tainan, Taiwan, 701
- National Cheng Kung University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: trunk exercise on unstable surface
trunk exercise training in supine and sitting positions, with unstable surfaces
|
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.
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Sham Comparator: upper limb range of motion exercise
upper limb range of motion exercise in sitting with back fully supported
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Upper limb range of motion exercise with trunk fully supported
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center of pressure
Time Frame: 6 weeks
|
range of displacement (cm)
|
6 weeks
|
Angular velocity of the non-affected arm raising
Time Frame: 6 weeks
|
mean velocity
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trunk Impairment Scale
Time Frame: 6 weeks
|
total score (0-23); higher scores mean better outcome
|
6 weeks
|
6-meter walking tests
Time Frame: 6 weeks
|
time (sec) to walk 6 meters
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2018
Primary Completion (Actual)
October 6, 2019
Study Completion (Actual)
October 6, 2019
Study Registration Dates
First Submitted
June 11, 2020
First Submitted That Met QC Criteria
June 15, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 15, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-ER-106-428
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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