NCT03477188

Brief Summary

This study was planned to evaluate the effects of somatosensory and vestibular rehabilitation additional conventional therapy on balance in patients with acute stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 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

September 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

March 16, 2018

Last Update Submit

March 24, 2018

Conditions

ExerciseAcute Stroke

Keywords

StrokeVestibularSomatosensoryRehabilitationBalance

Outcome Measures

Primary Outcomes (1)

  • Change from balance (Kore Balance score) of patients with acute stroke at 5-7 days a week.

    It used to measure static standing and dynamic balance ability by assessing posture imbalance, which was recorded as the anterior-to-posterior postural sway and the medial-to-lateral sway for 30 s. Kore Balance System facilitates the performance of a 4-way evaluation of the balance of front/left, front/right, behind/left, and behind/right and calculates total score. The total score, including deviations caused by impairment of postural balance, is calculated by the device. An increase in the total score indicates worse balance; that is, higher total scores indicate poorer balance and lower total scores, better balance . When the static and dynamic balance parameters of the hemiplegic participants were evaluated, the ground instability index was set to 5, with the participants' eyes open and their hands on the device. Our study included Kore Balance which evaluate dynamic and static balance with stroke and pressure of flor is arranged by physical therapist.

    5-7 days a week

Secondary Outcomes (6)

  • Change from control of body (Functional Reach (FRT)Test) of patients with acute stroke.

    5-7 days a week

  • Change from postural stability and control PASS (Postural Assessment Scale for Stroke) Rating Scale) of patients with acute stroke at 5-7 days a week

    5-7 days a week

  • Change from ambulation (Functional Ambulance Classification (FAS) Scale) of patients with acute stroke at 5-7 days a week.

    5-7 days a week

  • Visual Analog Scale (VAS)

    5-7 days a week

  • Change from muscle tone (Modified Ashworth (MASS)Scale) of patients with acute stroke at 5-7 days a week.

    5-7 days a week

  • +1 more secondary outcomes

Study Arms (2)

Somatosensorial and Vestibular Exercises Group

EXPERIMENTAL

This group of patients received patients with acute stroke. It will be applied somatosensorial and vestibular rehabilitation additional conventional therapy

Behavioral: Somatosensorial and Vestibular Exercises

Conventional Group

ACTIVE COMPARATOR

This Group patients received patient with acute stroke. It will be applied classical physiotherapy and conventional exercises.

Behavioral: Conventional Group

Interventions

Somatosensorial and Vestibular ExercisesBEHAVIORAL

In the experimental group, the subjects who were taken to the somatosensorial and vestibular exercises program after pre- treatment evaluations. The subjects in this group were given classical physiotherapy and somatosensorial combined with vestibular exercise performed 5-7 days a week, 1 set of 10 times with physiotherapist control. In the content of the training, in addition to the general physiotherapy program applied for Brunnstrom and Bobath exercises and spasticity inhibition according to in-bed mobility, Flask and spasticity conditions in the experimental group, a mutual study program was prepared with Cawthorne-Cooksey and Frenkel exercises in the bed, then balance and walking will be performed with the exercises

Somatosensorial and Vestibular Exercises Group
Conventional GroupBEHAVIORAL

In the control group, The subjects who were taken into the study were taken to the classical physiotherapy based on Bobath and Brunnstrom will be applied to increase the mobilization and spasticity up to the discharge stage known as 5-7 days a week

Conventional Group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inönü University Faculty of Medicine Neurology Department of patients with ischemic or hemorrhagic stroke diagnosed by department,
  • Co-operative,
  • In the age range 45-80,
  • Will be able to adapt to the exercise program,
  • To be involved in voluntary work,
  • Individuals who have been given their informed consent will be included in the study.

You may not qualify if:

  • Having incomplete infarction,
  • Having symptomatic lesions (abcess, tumor) with excessive bleeding risk or stroke,
  • Pulmonary complication,
  • If the training does not fit such as confusion or coma,
  • Patients with acute stroke who do not want to be involved in voluntary work will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (1)

  • Calisgan E, Talu B. The effect of vestibular and somatosensory rehabilitation in addition to early rehabilitation on balance after stroke: a randomized controlled trial. Top Stroke Rehabil. 2024 Oct;31(7):703-712. doi: 10.1080/10749357.2024.2318096. Epub 2024 Feb 19.

    PMID: 38373015DERIVED

MeSH Terms

Conditions

Motor ActivityStroke

Condition Hierarchy (Ancestors)

BehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Elisa Çalışgan, MsC

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants didn't know taking which exercise treatment methods.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental, Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Effects of Somatosensorial and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients with Acute Stroke

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 26, 2018

Study Start

September 30, 2017

Primary Completion

December 16, 2017

Study Completion

March 12, 2018

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)