StrokeHOMECIMTNCT01343602
Enhancing Participation of Chronic Stroke Patients by Constraint Induced Movement Therapy (HOMECIMT)
A study testing mod. Constraint-Induced Movement Therapy and Therapy as usual in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The aim of this study is to evaluate the efficacy of a modified approach of constraint induced movement therapy ("CIMT at home") for chronic stroke patients, compared to conventional physiotherapy and occupational therapy ("therapy as usual) with regard to the ability to participate in everyday activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- mod. Constraint-Induced Movement Therapy and Therapy as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Jun 2013
- 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
- age ≥ 18 years
- Stroke onset > 6 months prior to study enrollment
- upper extremity hemiparesis with impairment of hand and/or arm
- minimal function of the hand (at least 10º active wrist extension, at least 10º active of thumb abduction/extension, and at least 10º of extension two additional fingers)
- non-professional coach (e.g. family member)
- prescription of physical or occupational therapy
Who cannot join
- lack of knowledge of German
- serious impairment of verbal communication ability (e.g. severe aphasia)
- inability to consent (e.g. dementia)
- severe neuro-cognitive deficits (MMSE <23)
- terminal illness, life-threatening co-morbidity
- simultaneous participation in another treatment study targeting stroke recovery
- subjects may not have already received constraint induced movement therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)
The aim of this study is to evaluate the efficacy of a modified approach of constraint induced movement therapy ("CIMT at home") for chronic stroke patients, compared to conventional physiotherapy and occupational therapy ("therapy as usual) with regard to the ability to participate in everyday activities.
Read the detailed description
The study is a parallel cluster randomized controlled trial with therapy practices as clusters. After written consent from the patients, the therapists are randomly assigned to treat either the intervention or the control group. Blinded external assessors evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are quality of arm and hand use and arm and hand function. Assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes are analyzed with mixed models, which consider the hierarchical structure of the data, adjusted to the baseline measurements and sex. The primary analysis compares the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints are tested at the significance level of 5% each in hierarchical order.
- Conditions
- Stroke
- Being tested
- mod. Constraint-Induced Movement Therapy, Therapy as usual
- Keywords
- stroke, Constraint Induced Movement Therapy, participation, Physical Therapy, Occupational Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mod. Constraint-Induced Movement TherapyBehavioural
Therapists of the intervention group are trained in "CIMT at home". During an initial home visit the therapist determines together with the patient an individually tailored home training program focussing on everyday practice and instructs the non-professional coach. For four weeks the patients will perform 2 hours of daily training at home together with an instructed non-professional coach (e.g. family member) applying shaping techniques (i.e. 20 consecutive days). Patients are supposed to wear a resting hand splint for the entire treatment period for 4 to 6 hours daily. During the four weeks the therapist will provide 5 weekly visits at the patients' home to instruct and supervise the training.
Therapy as usualOther
Therapy as usual consists of the therapy, which is usually provided by the occupational or physical therapist. Therapy will be applied at the patients home or at the therapists' practice.
| Study group | Role | What they receive |
|---|---|---|
| mod. Constraint-Induced Movement Therapy | Experimental | CIMT at home is applied in the patients' home over the course of four weeks including (i.e. 20 consecutive days) 2 hours of daily training together with an instructed non-professional coach (e.g. family member) applying shaping techniques. Receives: Behavioral: mod. Constraint-Induced Movement Therapy |
| Therapy as usual | Other | Patients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes). Receives: Other: Therapy as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)
"Participation" defined as equal involvement in all aspects of society and daily living for people with disabilities is a composite outcome of the following two measures: The MAL-QOM is a self-administered measure of how well 30 daily activities are performed to assess the change in the quality of arm and hand use and the WMFT-PT, measured as the average time (in seconds) to complete 15 tasks, to evaluate the change in arm and hand function.
Measured: 4 weeks (post-treatment) relative to baseline performance
Secondary outcomes (6)
Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)
to assess the change in the quality and amount of arm and hand use
Measured: 3 and 6 months relative to baseline performance
Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)
to assess the change in time and quality of movement
Measured: 6 months relative to baseline performance
Nine-Hole Peg-Test
to assess finger dexterity
Measured: 4 weeks (post-treatment) and 6 months relative to baseline performance
Stroke-Impact-Scale (SIS)
to assess the impact on health and quality of life. A self-administered 59-item questionnaire, which assesses 8 domains of stroke (Strength, Hand Function, Activities of Daily Living / Instrumental Activities of Daily Living, Mobility, Communication, Emotion, Memory and Thinking, and Participation)
Measured: 4 weeks (post-treatment) and 6 months relative to baseline performance
Barthel Index(BI)
to assess functional disability i.e. to which somebody can function independently and has mobility in their activities of daily living (ADL)
Measured: 4 weeks (post-treatment) and 6 months relative to baseline performance
Instrumental Activities of Daily Living Scale (IADL)
to asses self-maintaining and instrumental activities of daily living
Measured: 4 weeks (post-treatment) and 6 months relative to baseline performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Anne Barzel, MD, Principal investigator, Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343602
- Sponsor's protocol ID
- BMBF-01-GX-1003
- Acronym
- HOMECIMT
- Status last verified
- Dec 2014
- First submitted
- 26 Apr 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Barzel A, Ketels G, Stark A, Tetzlaff B, Daubmann A, Wegscheider K, van den Bussche H, Scherer M. Home-based constraint-induced movement therapy for patients with upper limb dysfunction after stroke (HOMECIMT): a cluster-randomised, controlled trial. Lancet Neurol. 2015 Sep;14(9):893-902. doi: 10.1016/S1474-4422(15)00147-7. Epub 2015 Jul 28.
PubMed 26231624Barzel A, Ketels G, Tetzlaff B, Kruger H, Haevernick K, Daubmann A, Wegscheider K, Scherer M. Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial. Trials. 2013 Oct 14;14:334. doi: 10.1186/1745-6215-14-334.
PubMed 24124993
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)
- ClinicalTrials.gov ID
- NCT01343602
- Acronym / sponsor ID
- HOMECIMT / BMBF-01-GX-1003
- Conditions
- Stroke
- Keywords
- stroke, Constraint Induced Movement Therapy, participation, Physical Therapy, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Apr 2011 (estimated)
- 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.
The aim of this study is to evaluate the efficacy of a modified approach of constraint induced movement therapy ("CIMT at home") for chronic stroke patients, compared to conventional physiotherapy and occupational therapy ("therapy as usual) with regard to the ability to participate in everyday activities.
Detailed description
The study is a parallel cluster randomized controlled trial with therapy practices as clusters. After written consent from the patients, the therapists are randomly assigned to treat either the intervention or the control group. Blinded external assessors evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are quality of arm and hand use and arm and hand function. Assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes are analyzed with mixed models, which consider the hierarchical structure of the data, adjusted to the baseline measurements and sex. The primary analysis compares the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints are tested at the significance level of 5% each in hierarchical order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mod. Constraint-Induced Movement Therapy | Experimental | Behavioral: mod. Constraint-Induced Movement TherapyCIMT at home is applied in the patients' home over the course of four weeks including (i.e. 20 consecutive days) 2 hours of daily training together with an instructed non-professional coach (e.g. family member) applying shaping techniques. |
| Therapy as usual | Other | Other: Therapy as usualPatients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- Stroke onset > 6 months prior to study enrollment
- upper extremity hemiparesis with impairment of hand and/or arm
- minimal function of the hand (at least 10º active wrist extension, at least 10º active of thumb abduction/extension, and at least 10º of extension two additional fingers)
- non-professional coach (e.g. family member)
Key exclusion criteria (7 listed)
- lack of knowledge of German
- serious impairment of verbal communication ability (e.g. severe aphasia)
- inability to consent (e.g. dementia)
- severe neuro-cognitive deficits (MMSE <23)
- terminal illness, life-threatening co-morbidity
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 |
|---|---|---|
| mod. Constraint-Induced Movement TherapyTherapists of the intervention group are trained in "CIMT at home". During an initial home visit the therapist determines together with the patient an individually tailored home training program focussing on everyday practice and instructs the non-professional coach. For four weeks the patients will perform 2 hours of daily training at home together with an instructed non-professional coach (e.g. family member) applying shaping techniques (i.e. 20 consecutive days). Patients are supposed to wear a resting hand splint for the entire treatment period for 4 to 6 hours daily. During the four weeks the therapist will provide 5 weekly visits at the patients' home to instruct and supervise the training. | Behavioural | mod. Constraint-Induced Movement Therapy |
| Therapy as usualTherapy as usual consists of the therapy, which is usually provided by the occupational or physical therapist. Therapy will be applied at the patients home or at the therapists' practice. | Other | Therapy as usual |
Primary outcome
Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)
Time frame: 4 weeks (post-treatment) relative to baseline performance
"Participation" defined as equal involvement in all aspects of society and daily living for people with disabilities is a composite outcome of the following two measures: The MAL-QOM is a self-administered measure of how well 30 daily activities are performed to assess the change in the quality of arm and hand use and the WMFT-PT, measured as the average time (in seconds) to complete 15 tasks, to evaluate the change in arm and hand function.
6 secondary outcomes
Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)
Time frame: 3 and 6 months relative to baseline performance
Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)
Time frame: 6 months relative to baseline performance
Nine-Hole Peg-Test
Time frame: 4 weeks (post-treatment) and 6 months relative to baseline performance
Stroke-Impact-Scale (SIS)
Time frame: 4 weeks (post-treatment) and 6 months relative to baseline performance
Barthel Index(BI)
Time frame: 4 weeks (post-treatment) and 6 months relative to baseline performance
Instrumental Activities of Daily Living Scale (IADL)
Time frame: 4 weeks (post-treatment) and 6 months relative to baseline performance
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 16 Dec 2014.
- Derived from this study: PubMed 26231624Barzel A, Ketels G, Stark A, Tetzlaff B, Daubmann A, Wegscheider K, van den Bussche H, Scherer M. Home-based constraint-induced movement therapy for patients with upper limb dysfunction after stroke (HOMECIMT): a cluster-randomised, controlled trial. Lancet Neurol. 2015 Sep;14(9):893-902. doi: 10.1016/S1474-4422(15)00147-7. Epub 2015 Jul 28.
- Derived from this study: PubMed 24124993Barzel A, Ketels G, Tetzlaff B, Kruger H, Haevernick K, Daubmann A, Wegscheider K, Scherer M. Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial. Trials. 2013 Oct 14;14:334. doi: 10.1186/1745-6215-14-334.
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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.
Anne Barzel, MD principal investigator
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mod. Constraint-Induced Movement Therapy and Therapy as usual in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 7 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 16 Dec 2014. 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 Germany. 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?
Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT) (time frame: 4 weeks (post-treatment) relative to baseline performance). 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 NCT01343602, which also lists 2 linked publications.
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 16 Dec 2014.