NCT04792619

Brief Summary

There is a paucity of research on the correlation between postural control and upper extremity function. Analyzing the mechanisms of postural deficits and related problems is believed to give idea for any conceivable advance in future rehabilitation strategies in patients with stroke. The purpose of this study was to examine the effect of scapular exercises on the scapular stability and trunk control. We hypothesized that scapular exercises correct the scapular position and improve postural control. Hence the reaching out movement can be applied in a controlled and fluent manner at the end of the treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

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

December 3, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Scapular mobility

    Distance between medial border of scapula and columna vertebralis

    12 months

  • Trunk Impairment Scale

    postural control ability of the trunk

    12 months

  • Trunk Control Test

    Trunk Control

    12 months

  • Modified Barthel Index

    evaluate the level of disability during daily life activities

    12 months

  • Reaching Performance Test

    Reaching Performance

    12 months

Study Arms (2)

Control

EXPERIMENTAL
Other: Bobath Approach

Study

ACTIVE COMPARATOR
Other: Bobath ApproachOther: Isometric scapular exercises

Interventions

The patients in both groups were treated with the exercise program according to the Bobath concept was planned taking the functional needs of the survivors into account, including stretching and facilitation of latissimus dorsi muscle, facilitation of abdominal muscles, placing exercises, training of lumbar spine stabilizers, functional reach of shoulder in different directions. Five sessions of about an hour each were provided to the patients

ControlStudy

Isometric scapular exercises were performed to the patients included to the study group in a sitting position and at 900 of the shoulder flexion and 900 of the shoulder abduction. The patients were exercised by a physiotherapist using isometric contraction in protraction and retraction by a physiotherapist. Isometric contractions lasted 5 seconds and each exercise was repeated 2x15 times. One minute rest period was given between sets

Study

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as acute stroke, being able to sit without support, presence of hemiparesis, clinical stability

You may not qualify if:

  • Shoulder joint dysfunction due to previous musculoskeletal disease, severe dementia, severe visual disturbances that could not be corrected with glasses, severe aphasia, scored ≥ 3 on the Modified Ashworth Scale and refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Duray

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

December 3, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations