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CompletedNCT04434443Updated Jun 16, 2020

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

A Phase 1/2 interventional study of trunk exercise on unstable exercise and Upper limb range of motion exercise in Cerebrovascular Accident and Balance Impairment, sponsored by National Cheng Kung University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by National Cheng Kung University · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Aug 2018, registered Jun 2020).
Phase
Phase 1/2
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cerebrovascular Accident
  • Balance Impairment

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Keywords

  • stroke
  • balance
  • Trunk exercise
  • Trunk control
  • standing
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 35 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

National Cheng Kung University is the lead sponsor of 62 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • medically unstable
  • other neuromuscular/musculoskeletal problems that would affect balance
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    trunk exercise on unstable surface

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

    Other: trunk exercise on unstable exercise

  • Sham comparator
    upper limb range of motion exercise

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

    Other: Upper limb range of motion exercise

Interventions

  • Othertrunk 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.

  • OtherUpper limb range of motion exercise

    Upper limb range of motion exercise with trunk fully supported

06

What researchers measure

Primary outcomes

  1. Center of pressure

    range of displacement (cm)

    Time frame: 6 weeks

  2. Angular velocity of the non-affected arm raising

    mean velocity

    Time frame: 6 weeks

Secondary outcomes

  1. Trunk Impairment Scale

    total score (0-23); higher scores mean better outcome

    Time frame: 6 weeks

  2. 6-meter walking tests

    time (sec) to walk 6 meters

    Time frame: 6 weeks

07

Study locations

1 site
  • National Cheng Kung University
    Tainan, 701, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04434443
Lead sponsor
National Cheng Kung University
Collaborators
Tainan Hospital, Ministry of Health and Welfare
Responsible party
Sang-I Lin (Professor, Department of Physical Therapy, National Cheng Kung University, National Cheng Kung University) — Principal investigator
First posted
Jun 16, 2020
Start date
Aug 9, 2018
Primary completion
Oct 6, 2019
Completion
Oct 6, 2019
Last update
Jun 16, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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