Cerebrovascular AccidentPhase 1/2NCT04434443
Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke
A Phase 1/2 study testing trunk exercise on unstable exercise and Upper limb range of motion exercise in people with Cerebrovascular Accident and Balance Impairment, run by National Cheng Kung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cerebrovascular Accident, Balance Impairment
- What is being tested?
- trunk exercise on unstable exercise and Upper limb range of motion exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Aug 2018to 6 Oct 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: between 20-80 years old
- first time stroke
- could sit without back support at least 20 seconds
- could understand and follow experimental instructions
Who cannot join
- medically unstable
- other neuromuscular/musculoskeletal problems that would affect balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebrovascular Accident, Balance Impairment
- Being tested
- trunk exercise on unstable exercise, Upper limb range of motion exercise
- Keywords
- stroke, balance, Trunk exercise, Trunk control, standing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trunk exercise on unstable exerciseOther
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.
Upper limb range of motion exerciseOther
Upper limb range of motion exercise with trunk fully supported
| Study group | Role | What they receive |
|---|---|---|
| trunk exercise on unstable surface | Experimental | trunk exercise training in supine and sitting positions, with unstable surfaces Receives: Other: trunk exercise on unstable exercise |
| upper limb range of motion exercise | Sham comparator | upper limb range of motion exercise in sitting with back fully supported Receives: Other: Upper limb range of motion exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of pressure
range of displacement (cm)
Measured: 6 weeks
Angular velocity of the non-affected arm raising
mean velocity
Measured: 6 weeks
Secondary outcomes (2)
Trunk Impairment Scale
total score (0-23); higher scores mean better outcome
Measured: 6 weeks
6-meter walking tests
time (sec) to walk 6 meters
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start9 Aug 2018
- Primary completion6 Oct 2019
- Study completion6 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- Tainan Hospital, Ministry of Health and Welfare
- Responsible party
- Principal investigator, Sang-I Lin, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434443
- Sponsor's protocol ID
- B-ER-106-428
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trunk Exercise on Unstable Surface on Trunk Control and Balance in Persons With Stroke
- ClinicalTrials.gov ID
- NCT04434443
- Acronym / sponsor ID
- B-ER-106-428
- Conditions
- Cerebrovascular Accident, Balance Impairment
- Keywords
- stroke, balance, Trunk exercise, Trunk control, standing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Collaborators
- Tainan Hospital, Ministry of Health and Welfare
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 6 Oct 2019 (actual)
- Study completion
- 6 Oct 2019 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trunk exercise on unstable surface | Experimental | Other: trunk exercise on unstable exercisetrunk exercise training in supine and sitting positions, with unstable surfaces |
| upper limb range of motion exercise | Sham comparator | Other: Upper limb range of motion exerciseupper limb range of motion exercise in sitting with back fully supported |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age: between 20-80 years old
- first time stroke
- could sit without back support at least 20 seconds
- could understand and follow experimental instructions
Key exclusion criteria (2 listed)
- medically unstable
- other neuromuscular/musculoskeletal problems that would affect balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trunk exercise on unstable exerciseParticipants 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. | Other | trunk exercise on unstable surface |
| Upper limb range of motion exerciseUpper limb range of motion exercise with trunk fully supported | Other | upper limb range of motion exercise |
Primary outcome
Center of pressure
Time frame: 6 weeks
range of displacement (cm)
Angular velocity of the non-affected arm raising
Time frame: 6 weeks
mean velocity
2 secondary outcomes
Trunk Impairment Scale
Time frame: 6 weeks
6-meter walking tests
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing trunk exercise on unstable exercise and Upper limb range of motion exercise in people with Cerebrovascular Accident and Balance Impairment, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of pressure (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.