StrokeNCT01574079
Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
A study testing Traditional Physical Therapy and Physical Therapy plus Mirror Therapy in people with Stroke, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Traditional Physical Therapy and Physical Therapy plus Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- lower extremity Brunnstrom stage 2,
- lower extremity modified ashworth < 3,
- has the ability to follow 3-step command in English,
- has only unilateral involvement.
Who cannot join
- lower extremity Brunnstrom stage 1,
- lower extremity modified ashworth 3 or higher,
- history of prior stroke,
- Passive Range of Motion limitation of hip and or knee flexion < 90,
- has visual deficits which prevent participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center - University Rehabilitation
Jackson, Mississippi, 39216
About this study
Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.
Read the detailed description
Using a mirrored image of the uninvolved extremity superimposed upon the involved extremity during exercise may facilitate improved motor control in patients after stroke.
- Conditions
- Stroke
- Being tested
- Traditional Physical Therapy, Physical Therapy plus Mirror Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physical TherapyOther
Traditional physical therapy includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
Physical Therapy plus Mirror TherapyOther
The treatment group will receive traditional physical therapy intervention as described in the control group with the addition of mirror therapy. The participant will attempt to perform the flexion exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physical Therapy | Active comparator | The control group will receive traditional physical therapy interventions directed at neuromuscular rehabilitation. Receives: Other: Traditional Physical Therapy |
| Physical Therapy plus Mirror Therapy | Experimental | The mirror therapy will entail 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. Receives: Other: Physical Therapy plus Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure - Locomotor Score
The Functional Independence Measure (FIM)assesses level of disability and measures progress toward independence with rehabilitational intervention. The tool consists of 18 items. Only the the locomotor score was used to assess gait ability in this study. The locomotor score ranges from 1 - 7 with a higher score indicating a higher level of functional independence.
Measured: measured at admission and discharge from rehab estimated length of stay 14 days
Secondary outcomes (2)
Timed Up and Go
The Timed Up and Go (TUG) is used to assess balance and gait, and to estimate fall risks in patients with deficits. The participant rises from a seated position in a chair, walks 3 meters, turns around, returns to the chair, and sits down. The test is measured in seconds, with a lower number indicating a higher level of independence and the least risk for falls.
Measured: Measured at admission and discharge with estimated length of stay 14 days
Stroke Rehabilitation Assessment of Movement
The Stroke Rehabilitation Assessment of Movement (STREAM)is designed to measure mobility and motor ability after stroke. There are three subscales with 10 items each assessing the upper extremity, lower extremity, and basic mobility. Only the lower extremity and basic mobility items were used in this study. The lower extremity scores ranged from 0 - 18 with higher scores indicating a higher level of motor control. The basic mobility scores ranged from 0 - 30 with high numbers indicating a higher level of functional mobility.
Measured: measured at admission and discharge with estimated length of stay 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa J Barnes, University of Mississippi Medical Center
- Investigators
- Lisa J Barnes, PT DPT, Principal investigator, University of Mississippi Medical CenterKeri H McCullough, DPT, Study director, University of Mississippi Medical Center - University RehabilitationKim C Wilcox, PT MsPT PhD, Study director, University of Mississippi Medical Center - Director of Neurologic Residency Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574079
- Sponsor's protocol ID
- 2010-0244
- Status last verified
- Sep 2014
- First submitted
- 30 Jan 2012
- Last updated
- 11 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
- ClinicalTrials.gov ID
- NCT01574079
- Acronym / sponsor ID
- 2010-0244
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.
Detailed description
Using a mirrored image of the uninvolved extremity superimposed upon the involved extremity during exercise may facilitate improved motor control in patients after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Other: Traditional Physical TherapyThe control group will receive traditional physical therapy interventions directed at neuromuscular rehabilitation. |
| Physical Therapy plus Mirror Therapy | Experimental | Other: Physical Therapy plus Mirror TherapyThe mirror therapy will entail 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- lower extremity Brunnstrom stage 2,
- lower extremity modified ashworth < 3,
- has the ability to follow 3-step command in English,
- has only unilateral involvement.
Key exclusion criteria (5 listed)
- lower extremity Brunnstrom stage 1,
- lower extremity modified ashworth 3 or higher,
- history of prior stroke,
- Passive Range of Motion limitation of hip and or knee flexion < 90,
- has visual deficits which prevent participation.
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 |
|---|---|---|
| Traditional Physical TherapyTraditional physical therapy includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education. | Other | Traditional Physical Therapy |
| Physical Therapy plus Mirror TherapyThe treatment group will receive traditional physical therapy intervention as described in the control group with the addition of mirror therapy. The participant will attempt to perform the flexion exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities. | Other | Physical Therapy plus Mirror Therapy |
Primary outcome
Functional Independence Measure - Locomotor Score
Time frame: measured at admission and discharge from rehab estimated length of stay 14 days
The Functional Independence Measure (FIM)assesses level of disability and measures progress toward independence with rehabilitational intervention. The tool consists of 18 items. Only the the locomotor score was used to assess gait ability in this study. The locomotor score ranges from 1 - 7 with a higher score indicating a higher level of functional independence.
2 secondary outcomes
Timed Up and Go
Time frame: Measured at admission and discharge with estimated length of stay 14 days
Stroke Rehabilitation Assessment of Movement
Time frame: measured at admission and discharge with estimated length of stay 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Lisa J Barnes, PT DPT principal investigator
University of Mississippi Medical Center
Keri H McCullough, DPT study director
University of Mississippi Medical Center - University Rehabilitation
Kim C Wilcox, PT MsPT PhD study director
University of Mississippi Medical Center - Director of Neurologic Residency Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy and Physical Therapy plus Mirror Therapy in people with Stroke, run by University of Mississippi Medical Center at 1 site in United States.
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 5 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 Sep 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Independence Measure - Locomotor Score (time frame: measured at admission and discharge from rehab estimated length of stay 14 days). 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 11 Sep 2014.