Mirror Therapy in Older Adults Post-stroke

NCT04668963 | Unknown

• 1 other identifier: MIRROR-T
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Hemiplegia, Post-Ictal

Keywords

MIRROR THERAPY; OLDER ADULTS; STROKE

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (3)

• Hand strength

  3 months

• Fugl-Meyer test

  3 months

• Barthel Index

  3 months

Study Arms (2)

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.

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.

Device: MIRROR THERAPY

Interventions

MIRROR THERAPY 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.

INTENSIVE MIRROR THERAPY; SPACED OVER TIME MIRROR THERAPY

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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+).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead
• Complejo Asistencial Hermanas Hospitalarias del Sagrado Corazón de Jesús: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator

Study Sites (2)

Hospital Sagrado Corazon Malaga

Málaga, 29014, Spain

RECRUITING

Catholic University of Murcia

Murcia, 30107, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 31511629 BACKGROUND

MeSH Terms

Conditions

Hemiplegia; Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Juan José Hernández Morante, Ph.D.

  Catholic University of Murcia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan José Hernández Morante, Ph.D.

CONTACT

+34 968 278 808; jjhernandez@ucam.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The trial will be performed following a de facto masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: Forty subjects will be divided in two groups depending they were submitted to intensive or a more spaced over time therapy

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: September 1, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 21, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Locations

ES (2)