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Mirror Therapy in Older Adults Post-stroke

Primary Purpose

Hemiplegia, Post-Ictal

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MIRROR THERAPY
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia, Post-Ictal focused on measuring MIRROR THERAPY, OLDER ADULTS, STROKE

Eligibility Criteria

70 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Catholic University of MurciaRecruiting
  • Hospital Sagrado Corazon MalagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

INTENSIVE MIRROR THERAPY

SPACED OVER TIME MIRROR THERAPY

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Fugl-Meyer test
The Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) was employed. The patients with better physical performance demonstrated higher scores.
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

Full Information

First Posted
December 8, 2020
Last Updated
October 6, 2021
Sponsor
Universidad Católica San Antonio de Murcia
Collaborators
Complejo Asistencial Hermanas Hospitalarias del Sagrado Corazón de Jesús, Hospital Clínico Universitario Virgen de la Arrixaca
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1. Study Identification

Unique Protocol Identification Number
NCT04668963
Brief Title
Mirror Therapy in Older Adults Post-stroke
Official Title
Effectiveness of Intensively Applied Mirror Therapy on Older Adults With Post-stroke Hemiplegia: a Preliminary Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
Collaborators
Complejo Asistencial Hermanas Hospitalarias del Sagrado Corazón de Jesús, Hospital Clínico Universitario Virgen de la Arrixaca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Post-Ictal
Keywords
MIRROR THERAPY, OLDER ADULTS, STROKE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Forty subjects will be divided in two groups depending they were submitted to intensive or a more spaced over time therapy
Masking
ParticipantCare Provider
Masking Description
The trial will be performed following a de facto masking.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INTENSIVE MIRROR THERAPY
Arm Type
Experimental
Arm Description
The intensive therapy group participants received 5 Mirror Therapy (+physiotherapy) sessions /week for 6 weeks, which makes a total of 30 sessions.
Arm Title
SPACED OVER TIME MIRROR THERAPY
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MIRROR THERAPY
Intervention Description
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.
Primary Outcome Measure Information:
Title
MUSCLE ACTIVITY
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hand strength
Description
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.
Time Frame
3 months
Title
Fugl-Meyer test
Description
The Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) was employed. The patients with better physical performance demonstrated higher scores.
Time Frame
3 months
Title
Barthel Index
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan José Hernández Morante, Ph.D.
Phone
+34 968 278 808
Email
jjhernandez@ucam.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan José Hernández Morante, Ph.D.
Organizational Affiliation
Catholic University of Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan José Hernández Morante, PhD
First Name & Middle Initial & Last Name & Degree
Ana Belén Gámez Santiago, Ph.D.
First Name & Middle Initial & Last Name & Degree
Carlos Manuel Martínez Cáceres, Ph.D.
Facility Name
Hospital Sagrado Corazon Malaga
City
Málaga
ZIP/Postal Code
29014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Belén Gámez Santiago, Ph.D.
Phone
+34 677 25 52 88
Email
abgsfisio@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
A previous trial IPD have been allocated in an Internet database. At moment, we are still deciding to perform the same procedure.
Citations:
PubMed Identifier
31511629
Citation
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.
Results Reference
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Mirror Therapy in Older Adults Post-stroke

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