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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04434443
Other study ID # B-ER-106-428
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 9, 2018
Est. completion date October 6, 2019

Study information

Verified date June 2020
Source National Cheng Kung University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 balance. The results supported the hypothesis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date October 6, 2019
Est. primary completion date October 6, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
trunk exercise on unstable exercise
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 exercise
Upper limb range of motion exercise with trunk fully supported

Locations

Country Name City State
Taiwan National Cheng Kung University Tainan

Sponsors (2)

Lead Sponsor Collaborator
National Cheng Kung University Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center of pressure range of displacement (cm) 6 weeks
Primary Angular velocity of the non-affected arm raising mean velocity 6 weeks
Secondary Trunk Impairment Scale total score (0-23); higher scores mean better outcome 6 weeks
Secondary 6-meter walking tests time (sec) to walk 6 meters 6 weeks
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