StrokeNCT06671899
Nineteen Years of Modified CIMT in a Clinical Setting, to Improve Arm and Hand Function After Stroke
An observational study of Stroke and Neurological Diseases or Conditions, run by Region Jönköping County at 1 site in Sweden.
Trial summary
The goal of this observational study is to determine if clinically constraint-induced movement therapy (CIMT), when applied in a routine clinical practice, can improve arm- and hand function after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Neurological Diseases or Conditions
- What is being tested?
- Constraint-induced movement therapy (CIMT)
- How many people
- 87 participants
- Where
- 1 siteSweden
- Study dates
- 14 Aug 2000to 18 Dec 2018
- Phase
- Observational
- 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
Study population: Patients experiencing upper extremity impairments following neurological disorders who underwent a CIMT program at a multidisciplinary rehabilitation medicine clinic in Jönköping, Sweden during the years 2000 and 2018.
Who may be able to join
- Post-acute injury (participants had completed primary rehabilitation and were living at home)
- Reduced ability to use the hemi-paretic arm
- Ability to actively extend the metacarpophalangeal and the interphalangeal joints 10°
- Ability to actively extend the wrist 20°
Who cannot join
- Unable to walk and balance safely without using the non-affected hand, with or without a mobility aid
- Unable to understand the content of the training or lack of motivation
- Serious cognitive deficit or instable medical condition believed to affect training participation
- Pain in the affected arm believed to affect training intensity
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rehabilitation Medicine, Region Jönköping County
Jönköping, SE-551 85
About this study
Official title: Nineteen Years of Modified Constraint-Induced Movement Therapy in a Clinical Setting
The goal of this observational study is to determine if clinically constraint-induced movement therapy (CIMT), when applied in a routine clinical practice, can improve arm- and hand function after stroke. Additionally, the study seeks to identify which patients experienced the greatest improvements, and to examine factors that contribute to the long-term sustainability of the treatment.
Stroke is one leading cause of disability, often resulting in difficulties using the arm and hand function on one side, making daily activities challenging. CIMT aims to enhance arm and hand function after stroke by incorporating intensive training and restraining the non-affected limb, thereby encouraging the use of the affected arm and hand. While numerous studies have demonstrated the effectiveness of CIMT, and it is recommended in national clinical guidelines, it is rarely implemented in clinical practice due to challenges in execution and sustainability. Moreover, it remains unclear which patients benefit the most from the treatment.
Read more
At a rehabilitation clinic in Sweden, CIMT has been incorporated into routine care for 19 years, which is uncommon. Participants undergo CIMT as outpatients over a three-week period, with one patient being treated at a time. By retrospectively observe outcomes from this clinically implemented and sustained model of CIMT, the study aims to address the following questions:
- Is CIMT, when conducted in a regular clinical setting, effective?
- Are there relationships between patient characteristics and outcomes?
- Conditions
- Stroke, Neurological Diseases or Conditions
- Being tested
- Constraint-induced movement therapy (CIMT)
- Keywords
- stroke rehabilitation, physiotherapy, occupational therapy, neurological rehabilitation, upper extremity, CIMT, CI therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-induced movement therapy (CIMT)Other
Clinically implemented modified CIMT. Including the three main components; intensive and repetitive task-oriented training of the affected limb, constraint of the non-affected limb and behavioural strategies known as the Transfer Package. In this model the training is supervised by therapist from several professions and some training sessions is performed in group settings with other inpatients and outpatients undergoing primary rehabilitation at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| CIMT in a clinical setting | Those who underwent modified constraint-induced movement therapy in a clinical setting in Sweden during the years 2000-2018. Receives: Other: Constraint-induced movement therapy (CIMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient-Specific Functional Scale (PSFS)
The Patient-Specific Functional Scale is a self-reporting tool meticulously designed to capture and document activity performance challenges identified as significant by the patient. The patients rate their performance on a numeric rating scale from 0 to 10 (0, unable to perform activity; 10, able to perform activity without difficulties or at pre-injury level). In this study, patients autonomously selected 1-5 activities aligned with their personal goals and rated their performance using the PSFS (a mean score for the self-identified activities was labelled PSFS-self). Additionally, patients assessed a single predetermined activity, namely eating with a knife and fork; which was included in the exercise programme for all patients on a daily basis (labelled PSFS-KF).
Measured: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
Secondary outcomes (5)
Motor Activity Log (MAL)
MAL evaluates daily hand use. MAL consists of two assessment subscales including 30 common daily tasks (0, no use of the affected extremity; 5, normal use). The results are presented as mean values. One subscale concerns the quality of movement (QOM) and one subscale concerns the amount of use. In this study, only the MAL QOM subscale was applied.
Measured: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
The Box and Block Test (BBT)
The Box and Block Test (BBT) was used to measure gross manual dexterity. The test consists of a box with two compartments and 150 small blocks. The patient grasps and transport the blocks from one compartment to the other. The test score is the number of blocks transported in 60 s.
Measured: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
BL motor assessment
BL motor assessment is a measurement of motor function after stroke, modified after the Fugl-Meyer Assessment Scale. It includes assessment of the ability to perform active movements and rapid movement changes, balance, sensation, mobility, joint pain and passive range of motion. The test includes several parts but only the upper extremity active movements subpart for the affected side (maximum score 57 points) was used in this study. Each item score from 0 (no ability) to 3 (normal function) and the sum score is used with a maximum score for each side of 57 points for an upper extremity.
Measured: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
Active range of motion (AROM)
Active range of motion (AROM) was measured using a conventional goniometric technique (Hoppenfeld \& Hutton, 1976). The following joint movements were selected because of their big impact on daily activities: shoulder flexion, shoulder abduction, shoulder external rotation, elbow extension, supination and wrist extension. With no compensatory movements allowed, in a sitting position, the maximum AROM was measured and recorded in degrees.
Measured: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
Modified Ashworth Scale (MAS)
Spasticity in elbow and wrist flexors was assessed with the 6-level modified Ashworth Scale. The therapist measures the resistance to passive movement of a relaxed group of muscles and characterizes change in muscle tone (0, no increase in spasticity; 5, affected part is rigid in flexion or extension).
Measured: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start14 Aug 2000
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- Futurum - Academy for health and care
- Responsible party
- Principal investigator, Maria Landén, Region Jönköping County
- Investigators
- Kersti Samuelsson, Assoc.Prof., Study chair, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671899
- Sponsor's protocol ID
- 2019-02250
- Other IDs
- 2019
- Status last verified
- Nov 2024
- First submitted
- 15 Oct 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nineteen Years of Modified Constraint-Induced Movement Therapy in a Clinical Setting
- ClinicalTrials.gov ID
- NCT06671899
- Acronym / sponsor ID
- 2019-02250
- Conditions
- Stroke, Neurological Diseases or Conditions
- Keywords
- stroke rehabilitation, physiotherapy, occupational therapy, neurological rehabilitation, upper extremity, CIMT, CI therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- Futurum - Academy for health and care
- Study start
- 14 Aug 2000 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 4 Nov 2024 (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.
The goal of this observational study is to determine if clinically constraint-induced movement therapy (CIMT), when applied in a routine clinical practice, can improve arm- and hand function after stroke. Additionally, the study seeks to identify which patients experienced the greatest improvements, and to examine factors that contribute to the long-term sustainability of the treatment.
Stroke is one leading cause of disability, often resulting in difficulties using the arm and hand function on one side, making daily activities challenging. CIMT aims to enhance arm and hand function after stroke by incorporating intensive training and restraining the non-affected limb, thereby encouraging the use of the affected arm and hand. While numerous studies have demonstrated the effectiveness of CIMT, and it is recommended in national clinical guidelines, it is rarely implemented in clinical practice due to challenges in execution and sustainability. Moreover, it remains unclear which patients benefit the most from the treatment.
At a rehabilitation clinic in Sweden, CIMT has been incorporated into routine care for 19 years, which is uncommon. Participants undergo CIMT as outpatients over a three-week period, with one patient being treated at a time. By retrospectively observe outcomes from this clinically implemented and sustained model of CIMT, the study aims to address the following questions:
- Is CIMT, when conducted in a regular clinical setting, effective?
- Are there relationships between patient characteristics and outcomes?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIMT in a clinical setting | – | Other: Constraint-induced movement therapy (CIMT)Those who underwent modified constraint-induced movement therapy in a clinical setting in Sweden during the years 2000-2018. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing upper extremity impairments following neurological disorders who underwent a CIMT program at a multidisciplinary rehabilitation medicine clinic in Jönköping, Sweden during the years 2000 and 2018.
Key inclusion criteria (4 listed)
- Post-acute injury (participants had completed primary rehabilitation and were living at home)
- Reduced ability to use the hemi-paretic arm
- Ability to actively extend the metacarpophalangeal and the interphalangeal joints 10°
- Ability to actively extend the wrist 20°
Key exclusion criteria (4 listed)
- Unable to walk and balance safely without using the non-affected hand, with or without a mobility aid
- Unable to understand the content of the training or lack of motivation
- Serious cognitive deficit or instable medical condition believed to affect training participation
- Pain in the affected arm believed to affect training intensity
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 |
|---|---|---|
| Constraint-induced movement therapy (CIMT)Clinically implemented modified CIMT. Including the three main components; intensive and repetitive task-oriented training of the affected limb, constraint of the non-affected limb and behavioural strategies known as the Transfer Package. In this model the training is supervised by therapist from several professions and some training sessions is performed in group settings with other inpatients and outpatients undergoing primary rehabilitation at the clinic. | Other | CIMT in a clinical setting |
Primary outcome
The Patient-Specific Functional Scale (PSFS)
Time frame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
The Patient-Specific Functional Scale is a self-reporting tool meticulously designed to capture and document activity performance challenges identified as significant by the patient. The patients rate their performance on a numeric rating scale from 0 to 10 (0, unable to perform activity; 10, able to perform activity without difficulties or at pre-injury level). In this study, patients autonomously selected 1-5 activities aligned with their personal goals and rated their performance using the PSFS (a mean score for the self-identified activities was labelled PSFS-self). Additionally, patients assessed a single predetermined activity, namely eating with a knife and fork; which was included in the exercise programme for all patients on a daily basis (labelled PSFS-KF).
5 secondary outcomes
Motor Activity Log (MAL)
Time frame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
The Box and Block Test (BBT)
Time frame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
BL motor assessment
Time frame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
Active range of motion (AROM)
Time frame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
Modified Ashworth Scale (MAS)
Time frame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
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 15 Nov 2024.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Kersti Samuelsson, Assoc.Prof. study chair
Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Neurological Diseases or Conditions, run by Region Jönköping County at 1 site in Sweden.
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 4 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 15 Nov 2024. 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 Sweden. 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?
The Patient-Specific Functional Scale (PSFS) (time frame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.