Hemiplegia, Post-IctalNCT04668963
Mirror Therapy in Older Adults Post-stroke
A study testing MIRROR THERAPY in people with Hemiplegia, Post-Ictal, run by Universidad Católica San Antonio de Murcia at 2 sites in Spain.
Trial summary
Objective: The present work was carried out to determine the effectiveness of neuromuscular stimulation triggered by mirror therapy in older patients with post-stroke hemiplegia by two different intervention protocols, either intensively or spaced over time. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Hemiplegia, Post-Ictal
- What is being tested?
- MIRROR THERAPY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2020to 21 Dec 2021
- 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Voluntary aging patients (70-85 years-old) with ischaemic stroke diagnosed by imaging (CT or MR)
- To be included into physiotherapy therapy between two and six weeks after the stroke (mean of 20 ± 2 days)
- Brain damage and a significant limitation of hand extension and foot dorsiflexion stroke-derived without spasticity (Ashworth scale 1 or 1+).
Who cannot join
- Patients with haemorrhagic stroke
- With a surface EMG signal <0.5 μV
- With previous neurologic comorbidity which comprise muscle strength
- Patients with medical treatment which may affect muscle strength
- Patients with pacemaker
- Those with severe psychiatric conditions like cognitive decline or dementia (beyond the aging-related degenerative progression).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Sagrado Corazon Malaga
Málaga, 29014
Ana Belén Gámez Santiago, Ph.D., +34 677 25 52 88, abgsfisio@gmail.com
- Recruiting
Catholic University of Murcia
Murcia, 30107
Juan José Hernández Morante, PhD
Ana Belén Gámez Santiago, Ph.D.
About this study
Official title: Effectiveness of Intensively Applied Mirror Therapy on Older Adults With Post-stroke Hemiplegia: a Preliminary Trial.
Objective: The present work was carried out to determine the effectiveness of neuromuscular stimulation triggered by mirror therapy in older patients with post-stroke hemiplegia by two different intervention protocols, either intensively or spaced over time.
Design: Prospective longitudinal study Setting: Two Spanish rehabilitation centres. Participants: forty four aging patients (>70 y) with diagnosed post-stroke hemiplegia were randomly distributed to intensive intervention group (5 times/week for 6 weeks), or to spaced intervention group (3 times/week for 10 weeks) which were underwent to similar number of mirror therapy sessions (n=30).
Main outcome measures: Muscle strength and activity was measured at baseline and at the end of treatment. Functional ability was also evaluated.
Read the detailed description
INTRODUCTION:
Cerebral ischemia or intracranial haemorrhage are the main characteristics of cerebrovascular diseases like the stroke. The disruption of the functional neuronal integrity after a stroke can affect both motor and cognitive states. The most characteristic motor sequel of a stroke is hemiplegia, characterized by the loss of voluntary movement, muscle tone, and osteotendinous reflexes from the affected hemiparetic body.
Mirror therapy (MT) was born in the late 1990s and was initially used to treat "phantom limb" symptoms. More recently, the effectiveness of this therapy in motor rehabilitation on post-stroke hemiparetic limbs has been also described. Due to its low cost and simplicity, it has become one of the most widely used therapies. The purpose of the MT is to perform bilateral and synchronous movements with the non-paretic limb, creating an illusion of movement in the brain.
The effectiveness of MT on brain injury can be explained in three ways. First, mirror neurons can recognize an action and activate motor learning through imitation. Secondly, neurological damage from a stroke usually causes inflammation and oedema that interrupts the transmission of motor information. The illusion of movement created MT reawakens these motor pathways by reactivating them. Finally, after suffering a stroke, patients have a different degree of activity in their cerebral hemispheres, being much lower in the injured hemisphere. The performance of MT contributes to reducing this imbalance.
The MT is based on visual and somatosensory information that is processed in the central nervous system. The movements of the non-paretic limb reflected in the mirror create an illusion of normal movement of the affected limb. This neurophysiological phenomenon stimulates the same cortical areas that are active during movement observation (somatosensory cortex, premotor and primary motor cortex, supplementary motor area, cerebellum and basal ganglia). The mirror reflection leads to additional activation of the contralateral hemisphere to the perceived limb, producing an increase in the hemiparetic cortico-muscular excitability. However, despite its valuable role on patients with post-stroke hemiplegia, its effectiveness in older subjects has not been defined so clearly.
OBJECTIVE For all the above, the objective of the present study was to analyse the application and effectiveness of MT in older people (>70 years), and to compare the benefits between an intensively applied (5 times/week) MT protocol and a more spaced over time (3 times/week) procedure.
METHODOLOGY Design and participants will be explained elsewhere. Main outcome measures are muscle activity after intervention.
EXPECTED OUTCOMES We expect that all groups improved their muscle mobility and activity. Our data will confirm what intervention is more effective.
- Conditions
- Hemiplegia, Post-Ictal
- Being tested
- MIRROR THERAPY
- Keywords
- MIRROR THERAPY, OLDER ADULTS, STROKE
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRROR THERAPYDevice
patients were seated on a chair, with the mirror positioned between the upper limbs perpendicular to the subject's midline and with the unaffected upper limb facing the reflective surface. Following the physiotherapist indications, the patients observed the reflection of their unaffected limb while performing the following movements with the both arms, the affected one as good as possible: flexion and extension of the shoulder, elbow, wrist and finger, prone supination of the forearm.
| Study group | Role | What they receive |
|---|---|---|
| INTENSIVE MIRROR THERAPY | Experimental | The intensive therapy group participants received 5 Mirror Therapy (+physiotherapy) sessions /week for 6 weeks, which makes a total of 30 sessions. Receives: Device: MIRROR THERAPY |
| SPACED OVER TIME MIRROR THERAPY | Active comparator | The conventional therapy group received the same number of sessions but more spaced in time, consisting in 3 Mirror Therapy (+physiotherapy) sessions/week for 10 weeks. Receives: Device: MIRROR THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
MUSCLE ACTIVITY
The mean activity of the extensor and dorsiflexor muscles during all activity stages of each EMG session was analysed with a NEUROTRAC MYO-PLUS 2 (Verity Medical, UK), which was considered as an indicator of average muscle activity. The calculation excluded the first second of each activity period to eliminate the deviation from the first contraction attempt.
Measured: 3 months
Secondary outcomes (3)
Hand strength
The isometric strength (Nw) of the hand was assessed with a hand-held digital dynamometer (digital hand dynamometer, RMS Ltd., UK). The measurement was performed three times consecutively, with a 2-3-minute interval between measurements. Peak force values were recorded for each trial, and the median value was considered as the standard value, following the manufacturer's instructions.
Measured: 3 months
Fugl-Meyer test
The Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) was employed. The patients with better physical performance demonstrated higher scores.
Measured: 3 months
Barthel Index
The ability of the patients to perform basic daily living activities was determined through the Barthel index, which, in its Spanish translation, provided a Cronbach's alpha greater than 0.70
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Sep 2020
- Primary completion7 Dec 2020
- Study completion21 Dec 2021 (estimated)
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 Hemiplegia, Post-IctalStudies 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
- Forty subjects will be divided in two groups depending they were submitted to intensive or a more spaced over time therapy
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Asistencial Hermanas Hospitalarias del Sagrado Corazón de Jesús, Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Principal investigator, Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia
- Investigators
- Juan José Hernández Morante, Ph.D., Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668963
- Sponsor's protocol ID
- MIRROR-T
- Status last verified
- Oct 2021
- First submitted
- 8 Dec 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A previous trial IPD have been allocated in an Internet database. At moment, we are still deciding to perform the same procedure.
Publications
Gamez AB, Hernandez Morante JJ, Martinez Gil JL, Esparza F, Martinez CM. The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial. Sci Rep. 2019 Sep 11;9(1):13153. doi: 10.1038/s41598-019-49720-x.
PubMed 31511629
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intensively Applied Mirror Therapy on Older Adults With Post-stroke Hemiplegia: a Preliminary Trial.
- ClinicalTrials.gov ID
- NCT04668963
- Acronym / sponsor ID
- MIRROR-T
- Conditions
- Hemiplegia, Post-Ictal
- Keywords
- MIRROR THERAPY, OLDER ADULTS, STROKE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Collaborators
- Complejo Asistencial Hermanas Hospitalarias del Sagrado Corazón de Jesús, Hospital Universitario Virgen de la Arrixaca
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 21 Dec 2021 (estimated)
- First posted
- 16 Dec 2020 (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.
Objective: The present work was carried out to determine the effectiveness of neuromuscular stimulation triggered by mirror therapy in older patients with post-stroke hemiplegia by two different intervention protocols, either intensively or spaced over time.
Design: Prospective longitudinal study Setting: Two Spanish rehabilitation centres. Participants: forty four aging patients (>70 y) with diagnosed post-stroke hemiplegia were randomly distributed to intensive intervention group (5 times/week for 6 weeks), or to spaced intervention group (3 times/week for 10 weeks) which were underwent to similar number of mirror therapy sessions (n=30).
Main outcome measures: Muscle strength and activity was measured at baseline and at the end of treatment. Functional ability was also evaluated.
Detailed description
INTRODUCTION:
Cerebral ischemia or intracranial haemorrhage are the main characteristics of cerebrovascular diseases like the stroke. The disruption of the functional neuronal integrity after a stroke can affect both motor and cognitive states. The most characteristic motor sequel of a stroke is hemiplegia, characterized by the loss of voluntary movement, muscle tone, and osteotendinous reflexes from the affected hemiparetic body.
Mirror therapy (MT) was born in the late 1990s and was initially used to treat "phantom limb" symptoms. More recently, the effectiveness of this therapy in motor rehabilitation on post-stroke hemiparetic limbs has been also described. Due to its low cost and simplicity, it has become one of the most widely used therapies. The purpose of the MT is to perform bilateral and synchronous movements with the non-paretic limb, creating an illusion of movement in the brain.
The effectiveness of MT on brain injury can be explained in three ways. First, mirror neurons can recognize an action and activate motor learning through imitation. Secondly, neurological damage from a stroke usually causes inflammation and oedema that interrupts the transmission of motor information. The illusion of movement created MT reawakens these motor pathways by reactivating them. Finally, after suffering a stroke, patients have a different degree of activity in their cerebral hemispheres, being much lower in the injured hemisphere. The performance of MT contributes to reducing this imbalance.
The MT is based on visual and somatosensory information that is processed in the central nervous system. The movements of the non-paretic limb reflected in the mirror create an illusion of normal movement of the affected limb. This neurophysiological phenomenon stimulates the same cortical areas that are active during movement observation (somatosensory cortex, premotor and primary motor cortex, supplementary motor area, cerebellum and basal ganglia). The mirror reflection leads to additional activation of the contralateral hemisphere to the perceived limb, producing an increase in the hemiparetic cortico-muscular excitability. However, despite its valuable role on patients with post-stroke hemiplegia, its effectiveness in older subjects has not been defined so clearly.
OBJECTIVE For all the above, the objective of the present study was to analyse the application and effectiveness of MT in older people (>70 years), and to compare the benefits between an intensively applied (5 times/week) MT protocol and a more spaced over time (3 times/week) procedure.
METHODOLOGY Design and participants will be explained elsewhere. Main outcome measures are muscle activity after intervention.
EXPECTED OUTCOMES We expect that all groups improved their muscle mobility and activity. Our data will confirm what intervention is more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Forty subjects will be divided in two groups depending they were submitted to intensive or a more spaced over time therapy
| Arm | Type | Receives |
|---|---|---|
| INTENSIVE MIRROR THERAPY | Experimental | Device: MIRROR THERAPYThe intensive therapy group participants received 5 Mirror Therapy (+physiotherapy) sessions /week for 6 weeks, which makes a total of 30 sessions. |
| SPACED OVER TIME MIRROR THERAPY | Active comparator | Device: MIRROR THERAPYThe conventional therapy group received the same number of sessions but more spaced in time, consisting in 3 Mirror Therapy (+physiotherapy) sessions/week for 10 weeks. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Voluntary aging patients (70-85 years-old) with ischaemic stroke diagnosed by imaging (CT or MR)
- To be included into physiotherapy therapy between two and six weeks after the stroke (mean of 20 ± 2 days)
- Brain damage and a significant limitation of hand extension and foot dorsiflexion stroke-derived without spasticity (Ashworth scale 1 or 1+).
Key exclusion criteria (6 listed)
- Patients with haemorrhagic stroke
- With a surface EMG signal <0.5 μV
- With previous neurologic comorbidity which comprise muscle strength
- Patients with medical treatment which may affect muscle strength
- Patients with pacemaker
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 THERAPYpatients were seated on a chair, with the mirror positioned between the upper limbs perpendicular to the subject's midline and with the unaffected upper limb facing the reflective surface. Following the physiotherapist indications, the patients observed the reflection of their unaffected limb while performing the following movements with the both arms, the affected one as good as possible: flexion and extension of the shoulder, elbow, wrist and finger, prone supination of the forearm. | Device | INTENSIVE MIRROR THERAPY, SPACED OVER TIME MIRROR THERAPY |
Primary outcome
MUSCLE ACTIVITY
Time frame: 3 months
The mean activity of the extensor and dorsiflexor muscles during all activity stages of each EMG session was analysed with a NEUROTRAC MYO-PLUS 2 (Verity Medical, UK), which was considered as an indicator of average muscle activity. The calculation excluded the first second of each activity period to eliminate the deviation from the first contraction attempt.
3 secondary outcomes
Hand strength
Time frame: 3 months
Fugl-Meyer test
Time frame: 3 months
Barthel Index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Background: PubMed 31511629Gamez AB, Hernandez Morante JJ, Martinez Gil JL, Esparza F, Martinez CM. The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial. Sci Rep. 2019 Sep 11;9(1):13153. doi: 10.1038/s41598-019-49720-x.
- Individual participant dataSharing planned: Undecided. A previous trial IPD have been allocated in an Internet database. At moment, we are still deciding to perform the same procedure.
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.
Juan José Hernández Morante, Ph.D. principal investigator
Catholic University of Murcia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRROR THERAPY in people with Hemiplegia, Post-Ictal, run by Universidad Católica San Antonio de Murcia at 2 sites in Spain.
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 6 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: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan José Hernández Morante, Ph.D. (+34 968 278 808, jjhernandez@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MUSCLE ACTIVITY (time frame: 3 months). 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 NCT04668963, 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 7 Oct 2021.