Telerehabilitation to Improve Balance and Mobility in Patients After Stroke (TeleHome)

Telerehabilitation to Improve Balance and Mobility in Patients After Stroke: Group Physiotherapy Performed in Individuals' Homes

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Hemorrhagic Stroke
• Intervention / Treatment: Behavioral: Telerehabilitation

Detailed Description

Patients in the chronic post-stroke phase will be assessed for balance and mobility before and after remotely conducted group training. The training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate. The participants's balance and weight-bearing symmetry will be comprehensive assessed, as well their sit-to-stand ability, walking speed, and satisfaction with the remote training. Detailed inclusion and exclusion criteria are specified in the appropriate section.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Metka Moharić, MD, PhD; Phone Number: +386 1 4758441; Email: metka.moharic@ir-rs.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Rehabilitation Institute, Republic of Slovenia
    • Contact: Urška Puh, PT, PhD; Phone Number: +386 1 4758152; Email: urska.puh@ir-rs.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation group; Remote group training to improve balance and mobility	Behavioral: Telerehabilitation; The training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mobility	Assessed using 5 Times Sit-to-Stand test (measured in seconds; longer times a worse outcome)	Assessment 1-5 days before and 1-5 days after the training
Change in walking speed	Assessed using 10-Meter Walk Test (expressed in metres/second; higher speed means a better outcome)	Assessment 1-5 days before and 1-5 days after the training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the remote training	Assessed using the Modified Physical Activity Enjoyment Scale (scale score expressed as percentage; higher scores mean a better outcome)	Assessed 1-5 days after the training

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Investigators: Principal Investigator: Urška Puh, PT, PhD, University Rehabilitation Institute, Rehabilitation of Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Stroke; Telerehabilitation; Mobility
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: URIS202401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No