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

NCT05727111 | Recruiting

• 1 other identifier: B4032022000142b
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

HABIT-ILE; Intensive therapy based on motor skill learning; Home rehabilitation; Caregiver; Chronic Stroke; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT)

  Baseline, 2 weeks and 12 weeks after baseline

• Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test)

  Baseline, 2 weeks and 12 weeks after baseline

• Changes in the Six Minutes' Walk Test (6MWT)

  Baseline, 2 weeks and 12 weeks after baseline

• Changes in unimanual dexterity assessed by the Box & Block test (BBT)

  Baseline, 2 weeks and 12 weeks after baseline

• Changes in lower limbs physical activity

  During the 2 weeks of therapy

Study Arms (4)

HABIT-ILE therapy at home with a HABIT-ILE follow-up at home

EXPERIMENTAL

2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of HABIT-ILE follow-up at home

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home; Behavioral: Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home

HABIT-ILE therapy at home followed by usual care

EXPERIMENTAL

2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of usual care

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home; Behavioral: Usual care

Classic HABIT-ILE therapy followed by usual care

ACTIVE COMPARATOR

2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of usual care

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE); Behavioral: Usual care

Classic HABIT-ILE therapy with HABIT-ILE follow-up at home

ACTIVE COMPARATOR

2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of HABIT-ILE follow-up at home

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE); Behavioral: Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home

Interventions

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home BEHAVIORAL

The HABIT-ILE therapy at home will follow the same principles as the classic HABIT-ILE. The therapy will take place in the patient's home and a close person (caregiver) will accompany the patient during the therapy. A device will be used to facilitate the implementation of home therapy. Supervision of the therapeutic process will be done remotely by a team of trained supervisors. One hour of remote supervision per day will be scheduled within 6.5 hours of therapy.

Also known as: HABIT-ILE@home

HABIT-ILE therapy at home followed by usual care; HABIT-ILE therapy at home with a HABIT-ILE follow-up at home

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) BEHAVIORAL

HABIT-ILE ("Hand-Arm Bimanual Intensive Therapy including Lower Extremities") is an intensive therapy that continuously incorporates postural control and LE function. This motor learning-based approach include specificity of the practice, motivation, shaping of the task, intensive blocks of training and Hands-Off. Moreover, the therapy is goal-oriented to increase functional independence during daily living.

Also known as: Classic HABIT-ILE

Classic HABIT-ILE therapy followed by usual care; Classic HABIT-ILE therapy with HABIT-ILE follow-up at home

Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home BEHAVIORAL

HABIT-ILE follow-up at home follow the same principles as classic HABIT-ILE but is delivered at the patient home with 1 hour per day (4 hours per week in autonomy and 1 hour per week under supervision).

Also known as: Follow-up HABIT-ILE@home

Classic HABIT-ILE therapy with HABIT-ILE follow-up at home; HABIT-ILE therapy at home with a HABIT-ILE follow-up at home

Usual care BEHAVIORAL

Usual care is all the weekly physiotherapy and occupational therapy sessions that the patient usually receives.

Also known as: Customary care

Classic HABIT-ILE therapy followed by usual care; HABIT-ILE therapy at home followed by usual care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

MSL-IN lab, IoNS, UCLouvain

Brussels, 1200, Belgium

RECRUITING

Related Publications (4)

• 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.

  PMID: 17077374 BACKGROUND

• 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.

  PMID: 27679565 BACKGROUND

• 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.

  PMID: 23997396 BACKGROUND

• 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.

  PMID: 33825690 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yannick Bleyenheuft, Phd, Prof.

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick Bleyenheuft, Phd, Prof.

CONTACT

+32 486 91 99 11; yannick.bleyenheuft@uclouvain.be

Merlin Somville, Phd student

CONTACT

+32 477 08 26 77; merlin.somville@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The primary aim, the FMA, will be videotaped and the scoring will be done by a blind evaluator. In secondary outcomes, the WMFT will be blind scored.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The trial will be a single-blind, randomized, monocentric controlled trial. The trial start with a division in two arms HABIT-ILE therapy classic or at home then half of each group will benefit from a HABIT-ILE follow-up while the other will have usual care. That means that participants will be divided into four groups.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 14, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)