Constraint Induced Movement Therapy (CIMT) for acquired brain injury: a clinical feasibility RCT.

ISRCTN	ISRCTN22105243
DOI	https://doi.org/10.1186/ISRCTN22105243
Secondary identifying numbers	V2.09.07.09

Submission date: 19/01/2015
Registration date: 02/02/2015
Last edited: 19/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Having an acquired brain injury (stroke or traumatic) often results in difficulty with completing everyday tasks due to people having a decreased ability to use their arm effectively. This may often lead to a decreased quality of life and decreased independence in everyday activities. The aim of this study is to investigate how easy/difficult a therapy called Constraint Induced Movement Therapy (CIMT) is to deliver to patients and also to indicate if any improvements in their upper limb use occurs after using this therapy. It is hoped that this information will provide a better understanding of the therapy and show what further research is needed to be completed on the therapy.

Who can participate?
Both male and female patients, currently attending the Regional Acquired Brain Injury Unit (RABIU) in Musgrave Park Hospital are eligible to attend, providing they meet baseline arm movement requirements and upper limb treatment is a main therapy goal for the patient.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (experimental) are given CIMT for one and a half hours a day, 5 days per week for 3 weeks. Those in group 2 (control) are given standard (Bobath based) therapy over the same time period. Arm function, psychological effects (for example, improvements in depression or anxiety) and adherence to the treatment are assessed for all participants before their treatment starts, on the last day of treatment and then 12 weeks later.

What are the possible benefits and risks of participating?
There are both potential benefits and risks of taking part in the study including improvement in the amount and quality of movement in the patients’ arm. One potential risk is an increase in the amount of pain due to overuse of the arm; this will however be closely monitored by the therapy team and the therapy will be stopped or adapted if this occurs.

Where is the study run from?
Regional Acquired Brain Injury Unit -Belfast Health and Social Care Trust (UK)

When is the study starting and how long is it expected to run for?
September 2008 to September 2011

Who is funding the study?
Department of Employment and Learning, Northern Ireland (UK)

Who is the main contact?
Dr Katie Pedlow

Contact information

Dr Katy Pedlow
Public

1F122, University of Ulster
Centre for Health and Rehabilitation Technologies
Newtownabbey
BT37 OQB
United Kingdom

ORCID ID	0000-0002-7127-9032

Study information

Study design	Feasibility single-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Constraint Induced Movement Therapy (CIMT) for acquired brain injury: a clinical feasibility RCT investigating CIMT versus a Bobath based upper limb intervention.
Study objectives	Despite its robust evidence, gaps remain within CIMT research. The majority of studies have been completed in controlled laboratory settings in the United States of America and clinical settings in Asian countries such as China, Thailand and Taiwan; both of which are not directly comparable to the United Kingdom (UK) National Health Service (NHS). Although similarities could be drawn between the clinical settings of the UK and Asia, many differences exist such as the higher level of private healthcare in Asia (WHO 2009). To our knowledge there has only been one registered CIMT trial within the UK which is currently exploring web based CIMT (LifeCIT: NCT01350453); none have been completed in the UK clinical setting. In addition there have been no trials reporting the use of a multi disciplinary therapy team (both physiotherapists and occupational therapists) to deliver CIMT as well as very few trials investigating CIMT with the traumatic brain injury (TBI) population; the majority of research to date has focused on the stroke population. The aim of this current study was to address these research gaps and apply CIMT in the UK NHS clinical setting with both the stroke and traumatic brain injury population.
Ethics approval(s)	Northern Ireland Office for Research Ethics Committees, 11/11/2009, ref: 09/NIR01/53
Health condition(s) or problem(s) studied	Acquired brain injury, specifically traumatic brain injury and stroke.
Intervention	1. Constraint induced movement therapy for the upper limb (experimental) 2. Conventional interdisciplinary upper extremity programme (control)
Intervention type	Procedure/Surgery
Primary outcome measure	1. Motor activity log 2. Graded wolf motor function test The time points are baseline, immediately post intervention and three months post intervention completion
Secondary outcome measures	1. EuroQOL 2. Stroke self efficacy questionnaire 3. Hospital anxiety and depression scale The timepoints are baseline, immediately post intervention and three months post intervention completion
Overall study start date	28/09/2008
Completion date	01/09/2011

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	1. Participants with upper limb treatment as a main therapy requirement 2. Male and female (aged ≥ 18 years old) 3. Six months to five years post first episode of ABI (stroke or TBI) 4. Movement criteria: Have a minimum of the following criteria and be able to complete three times: 4.1. 100 wrist extension 4.2. 100 extension/abduction of the thumb 4.3. Extension of 2 fingers > 00 4.4 450 shoulder flexion and abduction 4.5. 200 elbow extension from 900 flexed position 5. Follow two part spoken or written commands 6. Perform their baseline level of mobility with the mitt on their less effected upper extremity including walking/transfer/wheelchair use (independently/with supervision/with assistance)
Key exclusion criteria	1. Progressive neurological condition 2. Gross cognitive impairment or disorientation.
Date of first enrolment	18/12/2009
Date of final enrolment	18/04/2011

Locations

Countries of recruitment

United Kingdom

Study participating centre

Regional Acquired Brain Injury Unit - Belfast Health and Social Care Trust

-
United Kingdom

Sponsor information

University of Ulster
University/education

Centre for Health and Rehabilitation Technologies
Newtownabbey
BT37 OQB
Northern Ireland
United Kingdom

"ROR"	https://ror.org/01yp9g959

Funders

Funder type

Government

Department of Employment and Learning, Northern Ireland (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	To be confirmed at a later date. 2013 results in thesis: https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.593635 (added 19/02/2020)
IPD sharing plan

Editorial Notes

19/02/2020: A thesis link has been added to the publication and dissemination plan.
07/06/2017: No publications found, verifying study status with principal investigator.