NCT04434443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

June 11, 2020

Last Update Submit

June 15, 2020

Conditions

Keywords

strokebalanceTrunk exerciseTrunk controlstanding

Outcome Measures

Primary Outcomes (2)

  • Center of pressure

    range of displacement (cm)

    6 weeks

  • Angular velocity of the non-affected arm raising

    mean velocity

    6 weeks

Secondary Outcomes (2)

  • Trunk Impairment Scale

    6 weeks

  • 6-meter walking tests

    6 weeks

Study Arms (2)

trunk exercise on unstable surface

EXPERIMENTAL

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

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

Other: Upper limb range of motion exercise

Interventions

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.

trunk exercise on unstable surface

Upper limb range of motion exercise with trunk fully supported

upper limb range of motion exercise

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: between 20-80 years old
  • first time stroke
  • could sit without back support at least 20 seconds
  • could understand and follow experimental instructions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor not aware of group assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Physical Therapy, National Cheng Kung University

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

August 9, 2018

Primary Completion

October 6, 2019

Study Completion

October 6, 2019

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations