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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06365463
Other study ID # URIS202401
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 9, 2024
Est. completion date May 31, 2024

Study information

Verified date April 2024
Source University Rehabilitation Institute, Republic of Slovenia
Contact Metka Moharic, MD, PhD
Phone +386 1 4758441
Email metka.moharic@ir-rs.si
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Slovenia University Rehabilitation Institute, Republic of Slovenia Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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
Primary Change in limits of stability Assessed using a force plate Assessment 1-5 days before and 1-5 days after the training
Primary Change in weight-bearing symmetry Assessed using a force plate Assessment 1-5 days before and 1-5 days after the training
Secondary 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
Secondary 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
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