StrokeNCT04584177
Arm-hand Boost Program During Inpatient Rehabilitation After Stroke
A study testing Arm-hand BOOST program in people with Stroke, run by Jessa Hospital at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Arm-hand BOOST program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 9 May 2019to 3 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arm-hand Boost Program During Inpatient Rehabilitation After Stroke: Pilot Randomized Controlled Trial
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.
- Conditions
- Stroke
- Being tested
- Arm-hand BOOST program, Control program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm-hand BOOST programBehavioural
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 programBehavioural
A dose-matched program of strengthening exercises for the lower limbs and general reconditioning
| Study group | Role | What they receive |
|---|---|---|
| Arm-hand BOOST + Control | Experimental | First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program Receives: Behavioral: Arm-hand BOOST program; Behavioral: Control program |
| Control + Arm-hand BOOST | Experimental | First 4 weeks control program, afterwards 4 weeks arm-hand boost program Receives: Behavioral: Arm-hand BOOST program; Behavioral: Control program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks
UL assessment - Function
Measured: Between baseline and first 4 weeks of study
Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks
UL assessment - Function
Measured: Between baseline and end of study (=8 weeks)
Change from Action Research Arm Test at 4 weeks
UL Assessment - Activities
Measured: Between baseline and first 4 weeks of study
Change from Action Research Arm Test at 8 weeks
UL Assessment - Activities
Measured: Between baseline and end of study (=8 weeks)
Secondary outcomes (8)
Change from Jebsen Taylor hand function test at 4 weeks
UL Assessment - Activities
Measured: Between baseline and first 4 weeks of study
Change from Jebsen Taylor hand function test at 8 weeks
UL Assessment - Activities
Measured: Between baseline and end of study (=8 weeks)
Change from Rivermead Motor Assessment Arm function at 4 weeks
UL Assessment - Activities
Measured: Between baseline and first 4 weeks of study
Change from Rivermead Motor Assessment Arm function at 8 weeks
UL Assessment - Activities
Measured: Between baseline and end of study (=8 weeks)
Change from Stroke upper limb capacity scale (SULCS) at 4 weeks
UL Assessment - Activities
Measured: Between baseline and first 4 weeks of study
Change from Stroke upper limb capacity scale (SULCS) at 8 weeks
UL Assessment - Activities
Measured: Between baseline and end of study (=8 weeks)
Change from Box & Block test at 4 weeks
UL Assessment - Activities
Measured: Between baseline and first 4 weeks of study
Change from Box & Block test at 8 weeks
UL Assessment - Activities
Measured: Between baseline and end of study (=8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start9 May 2019
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Meyer, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584177
- Sponsor's protocol ID
- Study 19.27
- Status last verified
- Aug 2020
- First submitted
- 4 Sep 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33716948
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arm-hand Boost Program During Inpatient Rehabilitation After Stroke: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04584177
- Acronym / sponsor ID
- Study 19.27
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-hand BOOST + Control | Experimental | Behavioral: Arm-hand BOOST program, Behavioral: Control programFirst 4 weeks arm-hand boost program, afterwards, 4 weeks of control program |
| Control + Arm-hand BOOST | Experimental | Behavioral: Arm-hand BOOST program, Behavioral: Control programFirst 4 weeks control program, afterwards 4 weeks arm-hand boost program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm-hand BOOST programThe 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. | Behavioural | Arm-hand BOOST + Control, Control + Arm-hand BOOST |
| Control programA dose-matched program of strengthening exercises for the lower limbs and general reconditioning | Behavioural | Arm-hand BOOST + Control, Control + Arm-hand BOOST |
Primary outcome
Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks
Time frame: Between baseline and first 4 weeks of study
UL assessment - Function
Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks
Time frame: Between baseline and end of study (=8 weeks)
UL assessment - Function
Change from Action Research Arm Test at 4 weeks
Time frame: Between baseline and first 4 weeks of study
UL Assessment - Activities
Change from Action Research Arm Test at 8 weeks
Time frame: Between baseline and end of study (=8 weeks)
UL Assessment - Activities
8 secondary outcomes
Change from Jebsen Taylor hand function test at 4 weeks
Time frame: Between baseline and first 4 weeks of study
Change from Jebsen Taylor hand function test at 8 weeks
Time frame: Between baseline and end of study (=8 weeks)
Change from Rivermead Motor Assessment Arm function at 4 weeks
Time frame: Between baseline and first 4 weeks of study
Change from Rivermead Motor Assessment Arm function at 8 weeks
Time frame: Between baseline and end of study (=8 weeks)
Change from Stroke upper limb capacity scale (SULCS) at 4 weeks
Time frame: Between baseline and first 4 weeks of study
Change from Stroke upper limb capacity scale (SULCS) at 8 weeks
Time frame: Between baseline and end of study (=8 weeks)
Change from Box & Block test at 4 weeks
Time frame: Between baseline and first 4 weeks of study
Change from Box & Block test at 8 weeks
Time frame: Between baseline and end of study (=8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 33716948Meyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Meyer, PhD principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm-hand BOOST program in people with Stroke, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks (time frame: Between baseline and first 4 weeks of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.