Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

NCT ID: NCT04584177

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2020-11-03

Brief Summary

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A pilot cross-over RCT including participants with sub-acute stroke is conducted in an inpatient rehabilitation setting. The experimental group (EG) receives an arm-hand boost program on top of their usual care program. The control group (CG) receives a dose-matched program of strengthening exercises for the lower limbs and general reconditioning. After 4 weeks, a cross-over is performed. Before, after 4 weeks and after 8 weeks of additional therapy, different clinical outcome measures for the upper limb are administered.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Arm-hand BOOST + Control

First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program

Group Type EXPERIMENTAL

Arm-hand BOOST program

Intervention Type BEHAVIORAL

The arm-hand boost program is provided 1 hour/day, 5x/week for 4 weeks, on top of their usual care program. The focus of the boost program is on scapula-setting, core-stability when reaching, movements with 30-60° flexion/abduction in shoulder, fine manipulation and integration in complex ADL tasks. Additionally, patients exercise 1 hour per week using the Armeo Power (Hocoma). Therefore, the additional arm-hand boost program consists of 24 one-hour sessions, provided over four weeks.

Control program

Intervention Type BEHAVIORAL

A dose-matched program of strengthening exercises for the lower limbs and general reconditioning

Control + Arm-hand BOOST

First 4 weeks control program, afterwards 4 weeks arm-hand boost program

Group Type EXPERIMENTAL

Arm-hand BOOST program

Intervention Type BEHAVIORAL

The arm-hand boost program is provided 1 hour/day, 5x/week for 4 weeks, on top of their usual care program. The focus of the boost program is on scapula-setting, core-stability when reaching, movements with 30-60° flexion/abduction in shoulder, fine manipulation and integration in complex ADL tasks. Additionally, patients exercise 1 hour per week using the Armeo Power (Hocoma). Therefore, the additional arm-hand boost program consists of 24 one-hour sessions, provided over four weeks.

Control program

Intervention Type BEHAVIORAL

A dose-matched program of strengthening exercises for the lower limbs and general reconditioning

Interventions

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Arm-hand BOOST program

The arm-hand boost program is provided 1 hour/day, 5x/week for 4 weeks, on top of their usual care program. The focus of the boost program is on scapula-setting, core-stability when reaching, movements with 30-60° flexion/abduction in shoulder, fine manipulation and integration in complex ADL tasks. Additionally, patients exercise 1 hour per week using the Armeo Power (Hocoma). Therefore, the additional arm-hand boost program consists of 24 one-hour sessions, provided over four weeks.

Intervention Type BEHAVIORAL

Control program

A dose-matched program of strengthening exercises for the lower limbs and general reconditioning

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* first stroke, as defined by WHO,
* minimal stay of 4 weeks in inpatient setting at study start
* minimally 18 years old
* being able to sit independently (trunk control test, item 3 = 25),
* motor impairment in the upper limb (Fugl-Meyer assessment, stage 2 (synergies): 8-17p, or stage 2: \<8p combined witht stage 5 (hand): \>6p
* sufficient cooperation to perform intervention and evaluations

Exclusion Criteria

* musculoskeletal and/or other neurological impairments with permanent damage that may hinder the study
* subdural hematoma, tumor, encephalitis, trauma, or other that lead to similar symptoms as stroke
* severe communication, cognitive or language impairments that hinder the investigations
* no written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Meyer, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

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Jessa Hospital, Campus Sint-Ursula

Herk-de-Stad, , Belgium

Site Status

Countries

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Belgium

References

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Meyer S, Verheyden G, Kempeneers K, Michielsen M. Arm-Hand Boost Therapy During Inpatient Stroke Rehabilitation: A Pilot Randomized Controlled Trial. Front Neurol. 2021 Feb 26;12:652042. doi: 10.3389/fneur.2021.652042. eCollection 2021.

Reference Type DERIVED
PMID: 33716948 (View on PubMed)

Other Identifiers

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Study 19.27

Identifier Type: -

Identifier Source: org_study_id

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