Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05518305 - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT03728738 - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke Phase 3
Terminated NCT03396419 - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting NCT05065216 - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) Phase 2/Phase 3
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A
Not yet recruiting NCT06462599 - Osteopontin Gene Polymorphism in Stroke Patients in Egypt
Not yet recruiting NCT06026696 - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Not yet recruiting NCT06032819 - Differentiating Between Brain Hemorrhage and Contrast
Recruiting NCT02910180 - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed NCT03554642 - Walkbot Robotic Training for Improvement in Gait Phase 3
Completed NCT02922452 - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects Phase 1
Withdrawn NCT01866189 - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke N/A
Recruiting NCT03041753 - Reperfusion Injury After Stroke Study N/A
Completed NCT02549846 - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial Phase 4
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Completed NCT01678534 - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial Phase 2