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Clinical Trials/NCT04434443
NCT04434443CompletedPhase 1

Effects of Trunk Exercise on Unstable Surface on Trunk Control and Balance in Persons With Stroke

National Cheng Kung University1 site in 1 country35 target enrollmentStarted: August 9, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
35
Locations
1
Primary Endpoint
Center of pressure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Outcome assessor not aware of group assignment

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

trunk exercise on unstable surface

Experimental

trunk exercise training in supine and sitting positions, with unstable surfaces

Intervention: trunk exercise on unstable exercise (Other)

upper limb range of motion exercise

Sham Comparator

upper limb range of motion exercise in sitting with back fully supported

Intervention: Upper limb range of motion exercise (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Trunk Impairment Scale(6 weeks)
  • 6-meter walking tests(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sang-I Lin

Professor, Department of Physical Therapy, National Cheng Kung University

National Cheng Kung University

Study Sites (1)

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