Stroke Clinical Trial
— HABITILEhomeOfficial title:
Implementation of a HABIT-ILE Intervention at Home for Individuals With Chronic Stroke: a Non-inferiority Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Adults with a chronic stroke (older than 6 months) - Ability to interact and understand simple instructions in order to complete assessments and therapy - Ability to perform a partial shoulder flexion or abduction, a partial elbow extension, and hold an object in the paretic hand - Availability of a caregiver for 6h30 per day during two weeks of therapy Exclusion Criteria: - Non controlled seizure - Botulinum toxin injection in the last 6 months before the first assessment or during the therapy - Intensive therapy in the last 6 months before the first assessment or during the therapy - Surgery that could affect the assessments or therapy in the last 6 months before the first assessment or during the therapy - Severe visual or cognitive impairments interfering with treatment and or assessments |
Country | Name | City | State |
---|---|---|---|
Belgium | MSL-IN lab, IoNS, UCLouvain | Brussel |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain |
Belgium,
Demers M, Fung K, Subramanian SK, Lemay M, Robert MT. Integration of Motor Learning Principles Into Virtual Reality Interventions for Individuals With Cerebral Palsy: Systematic Review. JMIR Serious Games. 2021 Apr 7;9(2):e23822. doi: 10.2196/23822. — View Citation
Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016. — View Citation
Stevenson T, Thalman L, Christie H, Poluha W. Constraint-Induced Movement Therapy Compared to Dose-Matched Interventions for Upper-Limb Dysfunction in Adult Survivors of Stroke: A Systematic Review with Meta-analysis. Physiother Can. 2012 Fall;64(4):397-413. doi: 10.3138/ptc.2011-24. — View Citation
Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in upper and lower extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA). | The FMA assess reflex activity, movement control and muscle strength in the upper and lower extremities of people with post-stroke hemiplegia. Maximum score is 100 points for motor score (Higher scores indicates better functioning levels). | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT) | The WMFT measures quantitative motor ability through 17 timed and functional tasks. Uses a 6-point ordinal scale (from 0= "does not attempt with the involved arm" to 5= "arm does participate; movement appears to be normal"). Maximum score is 75 (Higher scores indicates better functioning levels). | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test) | The miniBEST test is a shortened version of the Balance Evaluation Systems Test (BESTest). It assesses 6 different balance control systems, the BESTest was shortened based on factor analysis to include dynamic balance only (Higher scores indicate better performance). The test is a 14-item test scord on a 3-level ordinal scale (0-2). higher score means better performance. | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in the Six Minutes' Walk Test (6MWT) | The 6MWT assess endurance while walking 6 minutes without pause. More distance walked (in meters) indicate better performance. | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in unimanual dexterity assessed by the Box & Block test (BBT) | The BBT assess unimanual dexterity by quantifying the maximum of wooden blocks transferred from one space to the other during 1 minute (Higher scores indicate better performance). | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in lower limbs physical activity | With a movement sensor on each wrist and on the affected leg, the percentage of total time spent in movement (Standing, walking or sitting) is measured. Calculated in terms of the changes in the acceleration (m/s²). | During the 2 weeks of therapy | |
Secondary | Changes in upper limbs physical activity | With a movement sensor on each wrist and on the affected leg, the activities of both hand is quantified. Calculated in terms of the changes in the acceleration (m/s²). | During the 2 weeks of therapy | |
Secondary | Changes in Canadian Occupational Performance Measure (COPM) | In this interview, patients set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the patient's self-perception of performance and satisfaction of it. The total score is the average of the scores for perception and satisfaction separately (score from 1 to 10). | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in activities of daily living assessed by ABILHAND Questionnaire | The ABILHAND questionnaire specific to patients with chronic stroke measures a patient's manual ability to manage daily activities that require the use of the upper extremities, whatever the strategies involved, through 23 items. It ranges from -6 to +6 logits (higher score means better performance). | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire | The ACTIVLIM-Stroke questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or lower extremities through 20 items specific to patients after stroke. It ranges from - 6 to +6 logits (higher score means better performance). | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in the modified Rankin Scale (mRS) for neurologic disability | mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The 6 levels of disability goes from 0 ("no disability/no symptoms") to 5 ("disability requiring constant care for all needs"), being 6 "death". | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in the Stroke Impact Scale (SIS) | Self-reported questionnaire assessing multidimensional repercussions of the Stroke (strength, hand function, daily life activities, mobility, communication, emotion, memory, thinking and participation). Domains are scored on a metric of 0 to 100 (higher scores indicate better self-reported health). | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in the SATIS-STROKE scale | The SATIS-Stroke questionnaire is administered on an interview basis or preferentially self-administrated (patients do not realize the life situation). Patients are asked to estimate the satisfaction or dissatisfaction level in performing each life situation. During the evaluation, a 4-level response scale is presented to the patients. Patients are asked to rate their perception on the response scale as either "Very dissatisfied", "Dissatisfied", "Satisfied" or "Very satisfied". Life situations not attempted in the last month are not scored and are entered as missing responses. | Baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in the PILS-STROKE scale | The PILS-Stroke questionnaire self-administrated (patients do not realize the life situation). Patients are asked to estimate the participation or non-participation level in performing each life situation. During the evaluation, a 3-level response scale is presented to the patients. Patients are asked to rate their participation on the response scale as either "I do not participate", "I participate a little", "I participate a lot". Life situations that the patient do not want to participate in are rated with "?". | Baseline, 2 weeks and 12 weeks after baseline |
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