StrokeNCT02917343
Effect of Mirror Therapy and Task Oriented Training for Persons With Paretic Upper Extremity
A study testing mirror therapy and repetitive task training in people with Stroke and Cerebrovascular Accident, run by Quinnipiac University.
Trial summary
The purpose of the study is to determine the effect of a combined mirror therapy and task oriented/repetitive task training on upper extremity function of persons with hemiplegia due to cerebrovascular accident or stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- mirror therapy and repetitive task training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to give consent, complete home program
- minimal arm and hand use with the paretic limb
- onset of stroke of at least 3 months
Who cannot join
- >1 stroke episode
- significant cognitive and visual perceptual deficit
- lack of social support
About this study
Official title: Effect of Mirror Therapy and Repetitive Task Training on Upper Extremity Function for Persons With Subacute Stroke
The purpose of the study is to determine the effect of a combined mirror therapy and task oriented/repetitive task training on upper extremity function of persons with hemiplegia due to cerebrovascular accident or stroke.
Read the detailed description
This case series was designed to to determine the effect of a mirror therapy and repetitive task training program on the weak arm and hand functioning due to the consequences of stroke. Mirror therapy is a type of therapy mirror reflection of the stronger arm and hand helps to promote reorganization of neurons. Studies have shown that mirror therapy is an effective adjunct to regular exercise and task-oriented therapy.
To qualify for this study, participants must meet the following criteria: 1) age 21 years or more; 2) first-time stroke with onset of at least 3 months; 3) slight movement of the weaker arm or /and hand; 3) stable physical and mental health; and 4) mentally capable and competent to make health care-related decisions and carry out a home program.
Participants were required to come to Quinnipiac University - North Haven campus to undergo mirror therapy training, in 45-60 minute sessions, twice a week for one month. They were also required to complete pre-testing before and post-testing after the mirror therapy program. In addition, they were required to carry-out a home program that includes the use of a mirror box and self-selected tasks. The home program required them to exercise and practice the use of their more affected arm and hand for at least 1-2 hours a day.
Participation was strictly voluntary. Participants were informed of the minimal risks involved as well as their options to continue or withdraw from the study upon initial consent. The study did not yield physical or mental harm to the participants.
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- mirror therapy and repetitive task training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapy and repetitive task trainingBehavioural
Also called task oriented training
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | participants received 4 weeks of mirror therapy and repetitive task training Receives: Behavioral: mirror therapy and repetitive task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Specific Functional Scale
Patient Specific Functional Scale is a measure that involves self-rating of self-selected functional tasks
Measured: Change from baseline at 2 months
Change in Fugl Myer Motor Assessment
Fugl-Meyer Motor Assessment is a clinical performance test of motor ability of the upper extremity
Measured: Change from baseline at 2 months
Secondary outcomes (1)
Change in Motor Activity Log
The Motor Activity Log is a self-reported measure that captures the amount of arm and hand use and perception of movement quality of the impaired upper limb
Measured: Change from baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quinnipiac University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917343
- Sponsor's protocol ID
- 2614
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Bondoc S, Booth J, Budde G, Caruso K, DeSousa M, Earl B, Hammerton K, Humphreys J. Mirror Therapy and Task-Oriented Training for People With a Paretic Upper Extremity. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205080p1-7202205080p8. doi: 10.5014/ajot.2018.025064.
PubMed 29426386
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mirror Therapy and Repetitive Task Training on Upper Extremity Function for Persons With Subacute Stroke
- ClinicalTrials.gov ID
- NCT02917343
- Acronym / sponsor ID
- 2614
- Conditions
- Stroke, Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Quinnipiac UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Sep 2016 (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 purpose of the study is to determine the effect of a combined mirror therapy and task oriented/repetitive task training on upper extremity function of persons with hemiplegia due to cerebrovascular accident or stroke.
Detailed description
This case series was designed to to determine the effect of a mirror therapy and repetitive task training program on the weak arm and hand functioning due to the consequences of stroke. Mirror therapy is a type of therapy mirror reflection of the stronger arm and hand helps to promote reorganization of neurons. Studies have shown that mirror therapy is an effective adjunct to regular exercise and task-oriented therapy.
To qualify for this study, participants must meet the following criteria: 1) age 21 years or more; 2) first-time stroke with onset of at least 3 months; 3) slight movement of the weaker arm or /and hand; 3) stable physical and mental health; and 4) mentally capable and competent to make health care-related decisions and carry out a home program.
Participants were required to come to Quinnipiac University - North Haven campus to undergo mirror therapy training, in 45-60 minute sessions, twice a week for one month. They were also required to complete pre-testing before and post-testing after the mirror therapy program. In addition, they were required to carry-out a home program that includes the use of a mirror box and self-selected tasks. The home program required them to exercise and practice the use of their more affected arm and hand for at least 1-2 hours a day.
Participation was strictly voluntary. Participants were informed of the minimal risks involved as well as their options to continue or withdraw from the study upon initial consent. The study did not yield physical or mental harm to the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Behavioral: mirror therapy and repetitive task trainingparticipants received 4 weeks of mirror therapy and repetitive task training |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to give consent, complete home program
- minimal arm and hand use with the paretic limb
- onset of stroke of at least 3 months
Key exclusion criteria (3 listed)
- >1 stroke episode
- significant cognitive and visual perceptual deficit
- lack of social support
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 |
|---|---|---|
| mirror therapy and repetitive task trainingAlso: task oriented training | Behavioural | intervention arm |
Primary outcome
Change in Patient Specific Functional Scale
Time frame: Change from baseline at 2 months
Patient Specific Functional Scale is a measure that involves self-rating of self-selected functional tasks
Change in Fugl Myer Motor Assessment
Time frame: Change from baseline at 2 months
Fugl-Meyer Motor Assessment is a clinical performance test of motor ability of the upper extremity
1 secondary outcome
Change in Motor Activity Log
Time frame: Change from baseline at 2 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 28 Sep 2016.
- Derived from this study: PubMed 29426386Bondoc S, Booth J, Budde G, Caruso K, DeSousa M, Earl B, Hammerton K, Humphreys J. Mirror Therapy and Task-Oriented Training for People With a Paretic Upper Extremity. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205080p1-7202205080p8. doi: 10.5014/ajot.2018.025064.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing mirror therapy and repetitive task training in people with Stroke and Cerebrovascular Accident, run by Quinnipiac University.
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 3 inclusion and 3 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 in Patient Specific Functional Scale (time frame: Change from baseline at 2 months). The study lists 2 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 NCT02917343, 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 28 Sep 2016.