StrokeNCT03468504
Mirror Therapy and Treadmill Training for Patients With Chronic Stroke
A study testing Mirror Therapy and Treadmill in people with Stroke, run by Institute of Technology, Sligo at 1 site in Ireland.
Trial summary
This is a pilot randomised controlled trial investigating a combination of mirror therapy and treadmill training for the rehabilitation of lower limb impairment following a 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?
- Mirror Therapy and Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 1 Apr 2014to 10 Jan 2018
- 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
- Chronic stroke (greater than or equal to 6 months post stroke) with lower limb heimiparesis.
- Ambulatory with/without walking aid.
- Discharged from formal rehabilitation.
- A Mini Mental State Examination >/= 24.
Who cannot join
- Younger than 18 years
- Any additional illness that may prevent treadmill walking
- A Mini Mental State Examination < 24.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mirror Therapy and Treadmill Training for Patients With Chronic Stroke: A Pilot Randomised Controlled Trial
This is a pilot randomised controlled trial investigating a combination of mirror therapy and treadmill training for the rehabilitation of lower limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place at the institute. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.
Read the detailed description
The study necessitated patients with chronic stroke to walk on a treadmill while viewing a reflection of their non-affected limb in a mirror. There was also a placebo group and these patients walked on the treadmill and viewed a mirror in an altered position. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 30 participants were recruited. Patients attended the study for 30 minutes per day, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three month followup assessment. All assessments were carried out by a Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb motor function, muscle tone, walking speed and endurance.
- Conditions
- Stroke
- Being tested
- Mirror Therapy, Placebo Mirror Therapy, Treadmill
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyDevice
Also called Mirror Designed by IT Sligo.
Participants view the reflective side of a simple mirror which is placed in their mid-sagittal plane to view a mirror reflection of their non-affected limb for 30 mins per day, 3 days per week, for four weeks.
Placebo Mirror TherapyDevice
Also called Mirror Designed by IT Sligo.
Placebo Mirror Therapy: Participants view the reflective side of a simple mirror which is placed forward/ahead of them in their mid-sagittal plane, and thus cannot see a reflection of either lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks.
Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.
TreadmillDevice
Also called Variable speed Treadmill.
Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy & Treadmill Training | Experimental | Mirror Therapy: Participants view a mirror reflection of their non-affected limb which is placed in their mid-sagittal plane for 30 mins per day, 3 days per week, for four weeks.
Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. Receives: Device: Mirror Therapy; Device: Treadmill |
| Placebo Mirror & Treadmill Training | Placebo comparator | Placebo Mirror Therapy: Participants view a mirror which is placed forward/ahead of them in their mid-sagittal plane, and cannot see a reflection of any lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks.
Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. Receives: Device: Placebo Mirror Therapy; Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ten Metre Walk Test
Walking velocity measure. Lower times indicate an increased walking velocity.
Measured: 5 mins.
Six Minute Walk Test
Walking endurance measure. Larger distance indicates an improved walking endurance ability.
Measured: 10 mins
Secondary outcomes (2)
Modified Ashworth Scale
Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension).
Measured: 10 minutes
Fugl-Meyer Assessment-Lower extremity
Motor function outcome. Range 0 (Unable to do any functional Task) to 34 (Fully Independent in Functional Lower Extremity Tasks).
Measured: 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Apr 2014
- Primary completion10 Jan 2018
- Study completion10 Jan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomised Placebo Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Technology, Sligo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. John Bartlett, Institute of Technology, Sligo
- Investigators
- Patrick Broderick, PhD, Principal investigator, PhD researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468504
- Sponsor's protocol ID
- ITSligo
- Status last verified
- May 2018
- First submitted
- 19 Feb 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD is shared with any other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Therapy and Treadmill Training for Patients With Chronic Stroke: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03468504
- Acronym / sponsor ID
- ITSligo
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute of Technology, SligoUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 16 Mar 2018 (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.
This is a pilot randomised controlled trial investigating a combination of mirror therapy and treadmill training for the rehabilitation of lower limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place at the institute. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.
Detailed description
The study necessitated patients with chronic stroke to walk on a treadmill while viewing a reflection of their non-affected limb in a mirror. There was also a placebo group and these patients walked on the treadmill and viewed a mirror in an altered position. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 30 participants were recruited. Patients attended the study for 30 minutes per day, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three month followup assessment. All assessments were carried out by a Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb motor function, muscle tone, walking speed and endurance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Randomised Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy & Treadmill Training | Experimental | Device: Mirror Therapy, Device: TreadmillMirror Therapy: Participants view a mirror reflection of their non-affected limb which is placed in their mid-sagittal plane for 30 mins per day, 3 days per week, for four weeks. Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. |
| Placebo Mirror & Treadmill Training | Placebo comparator | Device: Placebo Mirror Therapy, Device: TreadmillPlacebo Mirror Therapy: Participants view a mirror which is placed forward/ahead of them in their mid-sagittal plane, and cannot see a reflection of any lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks. Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stroke (greater than or equal to 6 months post stroke) with lower limb heimiparesis.
- Ambulatory with/without walking aid.
- Discharged from formal rehabilitation.
- A Mini Mental State Examination >/= 24.
Key exclusion criteria (3 listed)
- Younger than 18 years
- Any additional illness that may prevent treadmill walking
- A Mini Mental State Examination < 24.
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 TherapyAlso: Mirror Designed by IT Sligo.Participants view the reflective side of a simple mirror which is placed in their mid-sagittal plane to view a mirror reflection of their non-affected limb for 30 mins per day, 3 days per week, for four weeks. | Device | Mirror Therapy & Treadmill Training |
| Placebo Mirror TherapyAlso: Mirror Designed by IT Sligo.Placebo Mirror Therapy: Participants view the reflective side of a simple mirror which is placed forward/ahead of them in their mid-sagittal plane, and thus cannot see a reflection of either lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks. Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. | Device | Placebo Mirror & Treadmill Training |
| TreadmillAlso: Variable speed Treadmill.Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. | Device | Mirror Therapy & Treadmill Training, Placebo Mirror & Treadmill Training |
Primary outcome
Ten Metre Walk Test
Time frame: 5 mins.
Walking velocity measure. Lower times indicate an increased walking velocity.
Six Minute Walk Test
Time frame: 10 mins
Walking endurance measure. Larger distance indicates an improved walking endurance ability.
2 secondary outcomes
Modified Ashworth Scale
Time frame: 10 minutes
Fugl-Meyer Assessment-Lower extremity
Time frame: 10 mins
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 14 May 2018.
- Individual participant dataSharing planned: No. No IPD is shared with any other researchers.
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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.
Patrick Broderick, PhD principal investigator
PhD researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy and Treadmill in people with Stroke, run by Institute of Technology, Sligo at 1 site in Ireland.
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 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 14 May 2018. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Ten Metre Walk Test (time frame: 5 mins.). 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?
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 14 May 2018; AzTrials last refreshed its copy on 31 Oct 2026.