Development and Validation of a Structured Tele-rehabilitation Programme of Brain Injured Patients

NCT06016374 | Recruiting

• 1 other identifier: 2022 474
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research project is to develop a tele-rehabilitation programme, which will constitute an original care pathway for brain damaged patients. It will aim to improve their impairments, activities and social participation. The programme will deliver a therapeutic education and self-education programme targeting the upper and lower limbs, and will assess the patients by means of a diary and self-evaluation questionnaires.

Conditions

Brain Injury, Vascular; Hemorrhagic Stroke; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• usability

  At the end of the trial, subjects will complete the System Usability Scale (SUS), a ten-item questionnaire evaluated on a Likert scale. This questionnaire is used to assess the usability of the TéléRé program. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.

  The test will be administered only once at the end of the intervention. So, 4 weeks after the start of the experiment, during the last session.

Study Arms (1)

telerehabilitation for post stroke patient

EXPERIMENTAL

During the study, the patient will be asked to use the TeleRé programme on the devices on a regular, daily basis, either in a hospital room or at home. They will also be asked to evaluate the programme via various questionnaires and assessments.

Other: telerehabilitation

Interventions

telerehabilitation OTHER

During this study, the patient will be asked to use the "TeleRé" programme at least 5 times a week for 30 minutes for one month. Through the programme, they will have access to exercises in video format and thus self-rehabilitation as well as serious therapeutic games. The self-education games and videos target the functional and motor recovery of the upper limb. In addition, cognitive functions (attention, memory, etc.) will also be stimulated via the programme. Therapeutic education modules and PROMS assessments will also be available.

telerehabilitation for post stroke patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present with an acute, subacute or chronic ischemic or hemorrhagic stroke,
• Be at least 18 years old,
• To be hospitalised in the neurorehabilitation unit.

You may not qualify if:

• Other neurological or musculoskeletal disease limiting their functional capacities,
• Pain in the upper limb making it impossible to mobilise.
• Inadaptability of the device to the patient's physiological position, especially in cases of contracture or severe spasticity.
• Severe cognitive disorders preventing the understanding of instructions.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Clinique Universitaires Saint-Luc

Brussels, Woluwé-Saint-Lambert, 1200, Belgium

RECRUITING

Related Publications (1)

• Van Durme M, Lejeune T, Stoquart G, Dehem S. Developing an mHealth App-based Telerehabilitation Programme for Stroke Survivors: A Feasibility and Usability Study. NeuroRehabilitation. 2025 Aug;57(1):103-110. doi: 10.1177/10538135251344925. Epub 2025 May 28.

  PMID: 40432510 DERIVED

MeSH Terms

Conditions

Cerebrovascular Trauma; Hemorrhagic Stroke; Ischemic Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Stroke

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Thierry Lejeune, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Lejeune, MD, PhD

CONTACT

+3227641648; thierry.lejeune@saintluc.uclouvain.be

Mathilde Van Durme

CONTACT

+3227641675; mathilde.vandurme@saintluc.uclouvain.be

Study Design

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

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: August 29, 2023
• Study Start: February 21, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)