Implementation of a HABIT-ILE Intervention at Home for Chronic Stroke — HABITILEhome  

Stroke Clinical Trial

Official title: Implementation of a HABIT-ILE Intervention at Home for Individuals With Chronic Stroke: a Non-inferiority Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

This study will use a randomized controlled trial design to assess the possible difference between two intensive treatment programs: a classic "Hand and Arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) therapy and a HABIT-ILE therapy implemented at the patient's home. Moreover, this study also aims to assess whether the patient's abilities are better with follow-up than without follow-up after two weeks of HABIT-ILE therapy. The possible difference between the therapies will be studied in terms of functional capacities, activities and social participation.

Clinical Trial Description

Strokes are one of the leading causes of disability in adults around the world, with a 24.9% risk of stroke for an adult over their lifetime. The main health problems caused by brain injury result in different symptoms from one patient to another. The consequences of these symptoms are highly variable and result in long-term functional deficits in activities of daily living, such as dressing, eating, going to the toilet, etc. To improve the autonomy of these patients, intensive therapies based on the principles of motor learning have proved to be particularly effective. Among these therapies, HABIT-ILE ("Hand-Arm Bimanual Intensive Therapy including Lower Extremities") has been developed over the past decade in the MSL-IN laboratory at UCLouvain and has shown impressive improvements in children with PC. For stroke, other intensive therapies based on the same principles, such as Constraint Induced Movement Therapy (CIMT), have proven to be more effective than usual care. As HABIT-ILE shares the same principles with CIMT and differs by being more functional by the use of both hands, lower extremities and trunk simultaneously, we can assume that HABIT-ILE should also be effective with stroke patients. In addition, preliminary data from other studies on the efficacy of HABIT-ILE in stroke patients are promising. HABIT-ILE is based on intensive training of bimanual activities, with the systematic inclusion of stimulation of motor control of the lower limbs and trunk. HABIT-ILE is based on intensive training of bimanual activities, with the systematic inclusion of stimulation of motor control of the lower limbs and trunk. This therapy takes the form of a rehabilitation camp of at least 50 hours, on site. Therefore, the implementation of a classic HABIT-ILE camp requires a great commitment from families who must go to the camp for two weeks of therapy. For patients living far from big cities or unable to travel, access to these therapies can be very complex. In addition, these camps are run in groups of 8 to 12 participants. Each participant is accompanied by at least one therapist (physiotherapist or occupational therapist) trained in HABIT-ILE therapy. This implies that a HABIT-ILE camp requires at least 12 trained therapists. Moreover, there is a lack of therapists which makes the implementation of these camps still difficult. In addition, COVID-19 health requirements make it difficult to implement any type of treatment and assess patient progress. This health crisis has highlighted the importance of being able to offer telerehabilitation sessions at home, with a remote health professional to supervise the therapy. To address the problem of accessibility and the lack of HABIT-ILE therapists, the idea of implementing HABIT-ILE at home was born. How could we apply the principles of motor learning at home? Some of the key elements of motor learning are intensity, shaping of the task (starting from a partial task and increasing difficulty), goal-oriented therapy, positive reinforcement and hands-off (voluntary movements by patients, not guided by the therapist). In addition, virtual reality is well adapted to help integrate these principles and allows remote communication with patients. However, these devices alone do not allow the implementation of all the principles of motor learning but with the supervision of therapists trained in HABIT-ILE supervision, this goal could be achieved. The purpose of this randomized controlled study is to assess whether HABIT-ILE at home is not inferior to conventional (camp) HABIT-ILE in terms of physical abilities, functional activities and social participation of participants. Both modalities will be carried out during two weeks with a pace of 6,5 hours per day for a total of 10 days. In addition, while the maintenance of skills during the HABIT-ILE camp at 3- and 6-months post-therapy has been proven, the issue of post-therapy improvement has not yet been studied. Indeed, we know that to maintain the skills acquired during the HABIT-ILE therapy, it is necessary to practice them daily. If a skill is not used, it will result in a cortical reorganization of the motor cortex to the detriment of that skill. Thus, there is a persistent cycle of decrease in use that leads to an unfavorable cortical reorganization that leads to a decrease in use, etc. This phenomenon is called "learned non-use". In order to reduce this phenomenon and thus improve the transfer of HABIT-ILE skills in the daily life of patients, we wonder about the benefits of post-therapy follow-up. Once again, the implementation of a HABIT-ILE protocol at home can provide us with a delocalized daily therapy solution implemented directly in the patient and supervised remotely. After the two weeks of the HABIT-ILE modality, we will set up a HABIT-ILE telerehabilitation follow-up for 9 weeks. This follow-up will be carried out over 9 weeks with a pace of 1 hour per day (except during the weekend, 5 hours/week). This study also aims to assess whether the patient's abilities are better with follow-up than without follow-up after two weeks of HABIT-ILE therapy. ;

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT05727111
• Study type: Interventional
• Source: Université Catholique de Louvain
• Contact: Yannick Bleyenheuft, Phd, Prof.
• Phone: +32 486 91 99 11
• Email: yannick.bleyenheuft@uclouvain.be
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Completion date: December 31, 2027