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Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease (INTeRAcT)

Primary Purpose

Stroke, Spinal Cord Injuries, Chronic Disease

Status

Recruiting

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Intensive rehabilitation programme

About this trial

This is an interventional treatment trial for Stroke focused on measuring rehabilitation, intensive, technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures; A diagnosis of central neurological disease, made by a specialist. Conditions may include stroke or spinal cord injury: Stroke: Participants must have received a diagnosis of stroke for the first time, have been diagnosed at least 3 months ago, and live at home. SCI: Participants have a rating A, B, C or D on the American Spinal Injury Association (ASIA) measurement scale, which refers to patients with complete or incomplete impairment. All levels of SCI can be included, if there is a clear patient need linked to the upper and/or lower extremities. At least 3 months post discharge from hospital/rehabilitation centre, living at home; Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM); Had a normal functional state prior to the pathology: a pre-pathology Barthel Index > 85/100; Unilateral or bilateral weakness of the affected upper or lower limbs (No maximum score in all affected limbs = motricity index: score 5 on 3/3 segments) Having the clinical opportunity to engage in exercise therapy with available technology, assessed by a specialist; Age of > 18 years; Sufficient cognitive ability to understand the games and give informed consent, assessed by a specialist;. Exclusion Criteria: Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist; No ability to initiate movements against gravity in the upper and lower limbs; Severe visual impairment, communication, cognitive and language formation problems that would prevent the intervention and measurement process, assessed by a specialist; Any disorder, which in the investigator's opinion might the compromise participant's safety or compliance with the CIP; Female who is pregnant, breast-feeding.

Sites / Locations

AZ HerentalsRecruiting
KU LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intensive rehabilitation program

Standard care

Arm Description

3 weeks of intensive rehabilitation --> follow-up 9 months standard care

Follow-up 9 months standard care --> 3 weeks of intensive rehabilitation

Outcomes

Primary Outcome Measures

Change in Functional Independence Measure (FIM)

The Functional Independence Measure (FIM), which measures independence in daily functioning after stroke. The FIM consists of 18 items designed to assess to what extent a person needs assistance in performing activities of daily living safely and efficiently. The activities consist of a number of basic skills related to self-care, pelvic floor function, transfers, gait, communication and social abilities. The FIM has acceptable reliability and has been found valid in people with stroke. Min: 13; Max: 91; Higher = better

Change in Spinal Cord Independence Measure (SCIM)

Spinal Cord Independence Measure (SCIM), an assessment of achievements of daily function of patients with spinal cord lesions. The scale consists of 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. The SCIM is valid and reliable. Min: 0; Max: 100; Higher = better

Secondary Outcome Measures

Change in The Canadian Occupational Performance Measure (COPM)

The Canadian Occupational Performance Measure (COPM), is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living, over time. This outcome can be used in both study populations. Min: 1; Max: 10; Higher = better

Change in EQ-5D-5L

EQ-5D-5L, measures quality of life at five levels of health (mobility, self-care, daily activities, pain/discomfort and anxiety/depression). From this, a weighted health index can be calculated for an individual or population. This scale can also be used for both populations. Min: 1; Max: 100; Higher = better

Change in Goal Attainment Scaling (GAS)

Goal Attainment Scaling (GAS), is an individualised evaluation method. It is scored on an ordinal 5-point scale, which captures a person's individual treatment goal and is scored afterwards on the achievement of that treatment goal. The GAS can and will be used for both stroke and spinal cord injury. Min: -2; Max: +2; Higher = better

Change in The fatigue severity scale (FSS)

The fatigue severity scale (FSS) contains 9 questions assessing the perceived severity of fatigue symptoms in the past week in various daily situations. The patient indicates the extent to which fatigue determines functioning. Again, this will be used for both stroke and spinal cord injury. Min: 9; Max: 63; Higher = worse

Borg Rating of Perceived Exertion Scale

During the intervention the Borg Rating of Perceived Exertion Scale will be completed to after every therapy block to assess subjective experiences of the patients during physical load. Min: 6; Max: 20; Higher = worse

Change in the 6-minute Walk-Test (6MWT)

The 6-minute Walk-Test (6MWT) is used to measure functional capacity. The maximum distance the patient can cover within 6 minutes is measured.

Change in the action research Arm Test (ARAT)

The action research Arm Test (ARAT) is an observational measure to assess upper extremity performance (coordination, dexterity and functioning), including 19 items. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Min: 0; Max: 57; Higher = better

Change in rhe Fugl-Meyer Assessment (FMA)

The Fugl-Meyer Assessment (FMA) is designed to assess motor functioning in upper and lower limbs, in patients with post-stroke. Patients are assessed on 50 test items and on an ordinal 3-point scale. Min: 0; Max: 100; Higher = better

Change in the functional Ambulation Classification (FAC)

The functional Ambulation Classification (FAC): is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient needs when walking, whether or not they use a personal assistive device. Min: 0; Max: 5; Higher = better

Change in the 10 Meter Walk Test (10MWT)

The 10 Meter Walk Test (10MWT) measures the time needed for a person to walk 10 meters. It is used to determine functional mobility and gait.

Change in the Stroke Self-efficacy Questionnaire

The Stroke Self-efficacy Questionnaire Evaluate individuals' confidence in carrying out activities of daily living. Min: 0; Max: 60; Higher = better

Full Information

NCT ID

NCT05970367

First Posted

June 23, 2023

Last Updated

July 24, 2023

Sponsor

KU Leuven

Collaborators

AZ Herentals, Vrije Universiteit Brussel

1. Study Identification

Unique Protocol Identification Number

NCT05970367

Brief Title

Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease

Acronym

INTeRAcT

Official Title

Impact of an Intensive Motor Rehabilitation Programme Integrating Technology for Adults With Central Neurological Disease: A Randomised Controlled Rehabilitation Study in the Chronic Phase

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 10, 2023 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

AZ Herentals, Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This project will consist of 1 large clinical trial with 2 core concepts: (1) Clinical benefits of an intensive rehabilitation programme using advanced technology, compared to the control group; (2) A full health economic evaluation combined with model-based estimation of costs and benefits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Spinal Cord Injuries, Chronic Disease

Keywords

rehabilitation, intensive, technology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomised controlled trial (RCT)

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensive rehabilitation program

Arm Type

Experimental

Arm Description

3 weeks of intensive rehabilitation --> follow-up 9 months standard care

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

Follow-up 9 months standard care --> 3 weeks of intensive rehabilitation

Intervention Type

Other

Intervention Name(s)

Intensive rehabilitation programme

Intervention Description

Intensive rehabilitation using advanced technology, based on the patient's goals. Including cardiovascular fitness training, goal-oriented training, physiotherapy with and without advanced technology and self-management.

Primary Outcome Measure Information:

Title

Change in Functional Independence Measure (FIM)

Description

Time Frame

Baseline - 3weeks - 9months

Title

Change in Spinal Cord Independence Measure (SCIM)

Description

Time Frame

Baseline - 3weeks - 9months

Secondary Outcome Measure Information:

Title

Change in The Canadian Occupational Performance Measure (COPM)

Description

Time Frame

Baseline - 3weeks - 9months

Title

Change in EQ-5D-5L

Description

Time Frame

Baseline - 3weeks - every month during follow-up - 9 months

Title

Change in Goal Attainment Scaling (GAS)

Description

Time Frame

Baseline - 3weeks - 9months

Title

Change in The fatigue severity scale (FSS)

Description

Time Frame

Baseline - 3weeks - 9months

Title

Borg Rating of Perceived Exertion Scale

Description

Time Frame

During intervention (up to 9 months)

Title

Change in the 6-minute Walk-Test (6MWT)

Description

The 6-minute Walk-Test (6MWT) is used to measure functional capacity. The maximum distance the patient can cover within 6 minutes is measured.

Time Frame