NCT04438343

Brief Summary

The objective of this study is to investigate the effects of the impairment-specific and augmented intervention based balance and strength training on turning performance in individuals with chronic stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 11, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

June 16, 2020

Last Update Submit

June 18, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Turning performance

    Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning

    Change from baseline at 4 week

Secondary Outcomes (6)

  • Balance

    Change from baseline at 4 week

  • Strength

    Change from baseline at 4 week

  • Straight walking performance

    Change from baseline at 4 week

  • Timed up and go test

    Change from baseline at 4 week

  • Falls Efficacy Scale International (Chinese)

    Change from baseline at 4 week

  • +1 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL
Other: Impairment-specific and augmented intervention

control group

ACTIVE COMPARATOR
Other: Conventional physical therapy

Interventions

Balance and lower extremities strength training

experimental group

Trunk and upper extremity training

control group

Eligibility Criteria

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

You may qualify if:

  • ≧ 6 months post first-ever stroke with unilateral motor deficits
  • ≧20 years of age
  • The ability to walk independently for at least 7 m with or without using walking aids
  • Score ≧ 24 of 30 on the Mini-Mental State Examination

You may not qualify if:

  • Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or superimposed sepsis)
  • History of other diseases known to interfere with participation in the study (e.g., heart failure, hemineglect, or diabetic neuropathy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yea-Ru Yang

Taipei, Beitou, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

September 11, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 22, 2021

Record last verified: 2021-06

Locations