NCT04985162

Brief Summary

The purpose of this study was to assess the effect or ordinary and differential learning based physiotherapy for torso control, balance and gait on subjects with ischemic stroke in the second phase of rehabilitation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

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 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

July 26, 2021

Last Update Submit

August 9, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Torso control assessment scale

    The torso control rating scale evaluates torso functions in a variety of locations, whether standing, sitting or performing a mobility assessment task. Each task was scored from 0 to 3 points: 0 - cannot perform task, 3 - can perfom task independently. Total test score is 36 and a higher total score meant a better trunk function.

    Baseline to 3 weeks

  • Berg balance test

    The Berg scale is used to assess a subject's static and dynamic balance. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4. The maximum obtainable score is 56. 0 points -are awarded to answers portraying the lowest level of function while 4 points are awarded to the highest level of function.

    Baseline to 3 weeks

  • Dynamic gait index is used to assess the likelihood of falling. A four-point ordinal scale, ranging from 0-3 points. Total maximum score is 24 points. 0 points indicates the lowest level of function and 3 points - the highest level of function.

    Dynamic gait index assessed the gait model, provided information about the person's balance while walking

    Baseline to 3 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group (n=10) received differential learning based physiotherapy program: 3 times a week ordinary physiotherapy, 2 times a week differential learning based on physiotherapy, total 3 weeks

Other: Intervention group

Control

ACTIVE COMPARATOR

Control group (n=10) received ordinary physiotherapy program 5 times a week, total 3 weeks

Other: Control group

Interventions

Differential learning based physiotherapy to improve torso control, balance and gait

Intervention

Ordinary physiotherapy program

Control

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients rehabilitated in Neurorabilitation Departmen of Lithuanian University of Health sciences hospital Kauno Kliniko in the second stage of rehabilitation;
  • Stroke for the first time;
  • m. age;
  • Able to go with aids;
  • Voluntary consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Sciences, Department of Rehabilitation

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were divided into intervention group and control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laura Smilgiene, physiotherapist, Lithuanian University of Health Science

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 2, 2021

Study Start

September 1, 2020

Primary Completion

March 8, 2021

Study Completion

March 12, 2021

Last Updated

August 16, 2021

Record last verified: 2021-08

Locations