NCT06365463

Brief Summary

Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

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

First Submitted

Initial submission to the registry

April 9, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

April 9, 2024

Last Update Submit

October 8, 2024

Conditions

Keywords

StrokeTelerehabilitationBalanceMobility

Outcome Measures

Primary Outcomes (3)

  • Change in balance

    Assessed using Mini-Balance Evaluation Systems Test (scale score range 0-28; higher scores mean a better outcome)

    Assessment 1-5 days before and 1-5 days after the training

  • Change in limits of stability

    Assessed using a force plate

    Assessment 1-5 days before and 1-5 days after the training

  • Change in weight-bearing symmetry

    Assessed using a force plate

    Assessment 1-5 days before and 1-5 days after the training

Secondary Outcomes (2)

  • Change in mobility

    Assessment 1-5 days before and 1-5 days after the training

  • Change in walking speed

    Assessment 1-5 days before and 1-5 days after the training

Other Outcomes (1)

  • Satisfaction with the remote training

    Assessed 1-5 days after the training

Study Arms (1)

Telerehabilitation group

EXPERIMENTAL

Remote group training to improve balance and mobility

Behavioral: Telerehabilitation

Interventions

The training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate.

Telerehabilitation group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic phase of ischemic or haemorrhagic stroke (\>6 months after stroke)
  • ability to walk independently on level ground or on all surfaces with or without a walking aid
  • mild balance deficit
  • sufficient cognitive and communicative abilities for participation
  • access to a personal computer with a camera, connected to the Internet

You may not qualify if:

  • stroke in the brainstem or cerebellum
  • additional neurological condition
  • musculoskeletal impairments that would interfere with the training
  • advanced heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Hemorrhagic StrokeIschemic StrokeStroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Urška Puh, PT, PhD

    University Rehabilitation Institute, Rehabilitation of Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 15, 2024

Study Start

April 9, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations