NCT05552742

Brief Summary

The study aimed to assess the effects of a virtual balance training program using the Thera-Trainer Balo (TTB) device along with conservative rehabilitation program on the clinical findings; standing, stepping, walking and balance measures; and activities of daily living in patients with stroke.

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 Nov 2021

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

November 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 21, 2022

Last Update Submit

September 21, 2022

Conditions

HemiplegiaStroke

Outcome Measures

Primary Outcomes (6)

  • Berg Balance Scale

    The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning

    Before Treatment

  • Berg Balance Scale

    The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning

    8 Week After Treatment

  • Functional Ambulation Scale

    Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.

    Before Treatment

  • Functional Ambulation Scale

    Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.

    8 Week After Treatment

  • Static and Dynamic Postural Stability Tests

    In the static postural stability test, two-legged standing, tandem standing, two-legged standing on a foam mat, tandem standing on a foam mat, one-legged standing, turning head and stopping on one leg, and one-legged standing on a foam mat were evaluated. The tasks of walking 25 steps on a foam mat and walking 25 steps on hard smooth ground were evaluated in dynamic postural stability test.

    Before Treatment

  • Static and Dynamic Postural Stability Tests

    In the static postural stability test, two-legged standing, tandem standing, two-legged standing on a foam mat, tandem standing on a foam mat, one-legged standing, turning head and stopping on one leg, and one-legged standing on a foam mat were evaluated. The tasks of walking 25 steps on a foam mat and walking 25 steps on hard smooth ground were evaluated in dynamic postural stability test.

    8 Week After Treatment

Secondary Outcomes (6)

  • Brunnstrom Stages

    Before Treatment

  • Brunnstrom Stages

    8 Week After Treatment

  • The Modified Ashworth Scale

    Before Treatment

  • The Modified Ashworth Scale

    8 Week After Treatment

  • Short Form-36 Quality of Life Scale

    Before Treatment

  • +1 more secondary outcomes

Study Arms (2)

Conservative Rehabilitation

ACTIVE COMPARATOR

Only conservative rehabilitation treatment was applied to the patients in group 1.

Other: Conservative rehabilitation

Conservative Rehabilitation + Virtual Balance Training

EXPERIMENTAL

Conservative rehabilitation treatment and virtual balance study were applied to the patients in group 2.

Other: Conservative rehabilitationDevice: Virtual Balance Training

Interventions

Conservative rehabilitationOTHER

The conservative rehabilitation program includes a patient-specific conservative exercise program comprising exercises that strengthen the paralyzed side, increase joint range of motion and strengthen muscles, stretch spastic muscles, and ensure balance rehabilitation that enhances balance performance and coordination. The patients in both groups received conservative rehabilitation program for 8 weeks, 4 days a week for 1 h.

Conservative RehabilitationConservative Rehabilitation + Virtual Balance Training
Virtual Balance TrainingDEVICE

Virtual balance training program using the Thera-Trainer Balo device was applied 4 times a week for a total of 8 weeks, and each session lasted for 20 min. The center of mass of each patient was determined using sensors and displayed on the screen. The patients were encouraged to move their mass by swiping in all directions via the apple picking game displayed on the screen

Conservative Rehabilitation + Virtual Balance Training

Eligibility Criteria

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

You may qualify if:

  • patients who had a cerebrovascular accident at least 6 months before the study,
  • patients had the first unilateral hemiparesis attack, could stand with or without assistance,
  • patients had no contraindications for walking.

You may not qualify if:

  • patients with a history of neurological diseases,
  • a mini-mental test score of \<24,
  • severe spasticity at the lower extremity with grade 4 and unilateral neglect, and musculoskeletal diseases such as amputation and severe arthritis, which limits walking,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HemiplegiaStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

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
Assistant Professor

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

November 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations

TU(1)