StrokeNCT03497650
Unilateral Strength Training and Mirror Therapy for Chronic Stroke Patients
A study testing Mirror Therapy and Cross-Education of Strengthening. 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 unilateral strength training (cross-education) and mirror therapy 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 Cross-Education of Strengthening.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIreland
- Study dates
- 22 Oct 2014to 16 Aug 2017
- 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 diagnosed by a physician at least 6 months prior to study begin Discharged from formal rehabilitation services (not receiving outpatient rehabilitation on more than a monthly basis, but may still be in receipt of occupational or language therapy).
Who cannot join
- Impaired cognition (Mini mental state examination (MMSE) < 21) Cardiovascular, neurological or musculoskeletal impairments of the lower extremity not related to stroke that would prevent strength training.
- Visual impairments that would interfere with the ability to participate safely in isometric training and observe mirror images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unilateral Strength Training and Mirror Therapy for Enhancing Lower Limb Motor Function Post Stroke: A Pilot Randomised Controlled Trial
This is a pilot randomised controlled trial investigating a combination of unilateral strength training (cross-education) and mirror therapy 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 assessments being conducted at the institute and all therapy sessions taking place at the participant's home. 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 perform a strength training programme with their less-affected lower limb. The mirror and strength training group observed the reflection of the training limb in a mirror, the strength training only group exercised without a mirror entirely. 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 35 participants were recruited. After a warm-up participants performed 4 sets of 5 maximal isometric ankle dorsiflexion contractions with their less-affected lower limb, 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 follow-up assessment. All assessments were carried out by a blinded Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb isometric strength, motor function, muscle tone, and self-perceived participation.
- Conditions
- Stroke
- Being tested
- Mirror Therapy, Cross-Education of Strengthening.
- 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
Mirror Therapy involved the patient sitting on a chair with a standard mirror placed between both legs with the reflective side of the mirror facing the non-affected leg. The patient is instructed to observe the reflection of the non-affected limb during the sessions. The patient was not given any instruction on the use of the affected limb.
Cross-Education of Strengthening.Other
Cross-education of strengthening involves training one side of the body with the intention of producing strengthening gains on both sides of the body. In this case the strengthening was done on the non-affected leg of each stroke patient.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy + Cross-Education. | Experimental | Patients performed 4 sets of 5 maximal isometric ankle dorsiflexions with their less-affected lower limb while observing the reflection of the exercising limb in the mirror which was placed in the patient's mid-sagittal plane. Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals. Receives: Device: Mirror Therapy; Other: Cross-Education of Strengthening. |
| Cross-Education of Strengthening. | Active comparator | Patients trained without a mirror entirely. They performed 4 sets of 5 maximal isometric ankle dorsiflexions with their less-affected lower limb. Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals. Receives: Other: Cross-Education of Strengthening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Isometric ankle dorsiflexion Strength.
Assessed with the Biodex System 3 Pro Isokinetic Dynamometer with the Biodex Advantage Software version 3.45 (Biodex Medical Systems, Inc., Shirley, New York, USA). Peak Torque, Rate of Torque Development and Average Torque over a single contraction was analysed. A higher torque measurement indicates a greater contraction strength.
Measured: 10 minutes
Secondary outcomes (4)
Modified Ashworth Scale (MAS).
Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension).
Measured: 10 minutes.
Timed Up and Go (TUG).
Assessment of the International Classification of Functioning, Disability and Health activity level. Used to measure basic mobility and balance manoeuvres; the ability to perform sequential motor tasks relative to walking and turning. Minimal Detectable Change = 2.9 seconds. A faster time indicates better functional ability.
Measured: 5 minutes.
10 Metre Walk Test (10MWT).
Assessment of the International Classification of Functioning, Disability and Health activity level. Used to assess walking velocity in metres per second (m/s) over a short duration. Lower times indicate an increased walking velocity. Minimal Clinically Important Difference (MCID) is reported as; Small meaningful change = 0.06 m/s and Substantial meaningful change = 0.14 m/s. A higher score indicates a faster walking velocity.
Measured: 5 minutes.
London Handicap Scale (LHS).
Measurement of self-perceived impact of stroke over 6 domains of a patient's life (mobility, physical independence, occupation, social integration, orientation, and economic self - sufficiency). Scoring range of 0 to 1, where a score of 1 indicated 'No Disadvantage and a score of 0 indicates 'most severe disadvantage'.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start22 Oct 2014
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
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 Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 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
- Daniel Simpson, PhD, Principal investigator, IT Sligo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497650
- Sponsor's protocol ID
- ITSligo Daniel Simpson
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2018
- Last updated
- 13 Apr 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 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Strength Training and Mirror Therapy for Enhancing Lower Limb Motor Function Post Stroke: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03497650
- Acronym / sponsor ID
- ITSligo Daniel Simpson
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Institute of Technology, SligoUniversity, hospital or other
- Study start
- 22 Oct 2014 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 13 Apr 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 unilateral strength training (cross-education) and mirror therapy 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 assessments being conducted at the institute and all therapy sessions taking place at the participant's home. 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 perform a strength training programme with their less-affected lower limb. The mirror and strength training group observed the reflection of the training limb in a mirror, the strength training only group exercised without a mirror entirely. 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 35 participants were recruited. After a warm-up participants performed 4 sets of 5 maximal isometric ankle dorsiflexion contractions with their less-affected lower limb, 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 follow-up assessment. All assessments were carried out by a blinded Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb isometric strength, motor function, muscle tone, and self-perceived participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy + Cross-Education. | Experimental | Device: Mirror Therapy, Other: Cross-Education of Strengthening.Patients performed 4 sets of 5 maximal isometric ankle dorsiflexions with their less-affected lower limb while observing the reflection of the exercising limb in the mirror which was placed in the patient's mid-sagittal plane. Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals. |
| Cross-Education of Strengthening. | Active comparator | Other: Cross-Education of Strengthening.Patients trained without a mirror entirely. They performed 4 sets of 5 maximal isometric ankle dorsiflexions with their less-affected lower limb. Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic stroke diagnosed by a physician at least 6 months prior to study begin Discharged from formal rehabilitation services (not receiving outpatient rehabilitation on more than a monthly basis, but may still be in receipt of occupational or language therapy).
Key exclusion criteria (2 listed)
- Impaired cognition (Mini mental state examination (MMSE) < 21) Cardiovascular, neurological or musculoskeletal impairments of the lower extremity not related to stroke that would prevent strength training.
- Visual impairments that would interfere with the ability to participate safely in isometric training and observe mirror images.
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 TherapyMirror Therapy involved the patient sitting on a chair with a standard mirror placed between both legs with the reflective side of the mirror facing the non-affected leg. The patient is instructed to observe the reflection of the non-affected limb during the sessions. The patient was not given any instruction on the use of the affected limb. | Device | Mirror Therapy + Cross-Education. |
| Cross-Education of Strengthening.Cross-education of strengthening involves training one side of the body with the intention of producing strengthening gains on both sides of the body. In this case the strengthening was done on the non-affected leg of each stroke patient. | Other | Cross-Education of Strengthening., Mirror Therapy + Cross-Education. |
Primary outcome
Maximal Isometric ankle dorsiflexion Strength.
Time frame: 10 minutes
Assessed with the Biodex System 3 Pro Isokinetic Dynamometer with the Biodex Advantage Software version 3.45 (Biodex Medical Systems, Inc., Shirley, New York, USA). Peak Torque, Rate of Torque Development and Average Torque over a single contraction was analysed. A higher torque measurement indicates a greater contraction strength.
4 secondary outcomes
Modified Ashworth Scale (MAS).
Time frame: 10 minutes.
Timed Up and Go (TUG).
Time frame: 5 minutes.
10 Metre Walk Test (10MWT).
Time frame: 5 minutes.
London Handicap Scale (LHS).
Time frame: 10 minutes
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 13 Apr 2018.
- Individual participant dataSharing planned: No. No IPD is shared with any other researchers.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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.
Daniel Simpson, PhD principal investigator
IT Sligo
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 Cross-Education of Strengthening. 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 1 inclusion and 2 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 13 Apr 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. 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?
Maximal Isometric ankle dorsiflexion Strength. (time frame: 10 minutes). 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 13 Apr 2018.