Mirror Therapy in Older Adults Post-stroke

NCT ID: NCT04668963

Last Updated: 2021-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-21

Brief Summary

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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

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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

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Hemiplegia, Post-Ictal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Forty subjects will be divided in two groups depending they were submitted to intensive or a more spaced over time therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
The trial will be performed following a de facto masking.

Study Groups

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INTENSIVE MIRROR THERAPY

The intensive therapy group participants received 5 Mirror Therapy (+physiotherapy) sessions /week for 6 weeks, which makes a total of 30 sessions.

Group Type EXPERIMENTAL

MIRROR THERAPY

Intervention Type DEVICE

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.

SPACED OVER TIME MIRROR THERAPY

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.

Group Type ACTIVE_COMPARATOR

MIRROR THERAPY

Intervention Type DEVICE

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.

Interventions

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MIRROR THERAPY

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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+).

Exclusion Criteria

* 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).
Minimum Eligible Age

70 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Complejo Asistencial Hermanas Hospitalarias del Sagrado Corazón de Jesús

UNKNOWN

Sponsor Role collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role collaborator

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Juan Jose Hernández Morante

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan José Hernández Morante, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Murcia

Locations

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Hospital Sagrado Corazon Malaga

Málaga, , Spain

Site Status RECRUITING

Catholic University of Murcia

Murcia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan José Hernández Morante, Ph.D.

Role: CONTACT

+34 968 278 808

Facility Contacts

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Ana Belén Gámez Santiago, Ph.D.

Role: primary

+34 677 25 52 88

Juan José Hernández Morante, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31511629 (View on PubMed)

Other Identifiers

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MIRROR-T

Identifier Type: -

Identifier Source: org_study_id

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