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Unilateral Strength Training and Mirror Therapy for Chronic Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Mirror Therapy
Cross-Education of Strengthening.
Sponsored by
Institute of Technology, Sligo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

  • Institute of Technology, Sligo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mirror Therapy + Cross-Education.

Cross-Education of Strengthening.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Modified Ashworth Scale (MAS).
Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension).
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.
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.
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'.

Full Information

First Posted
March 24, 2018
Last Updated
April 6, 2018
Sponsor
Institute of Technology, Sligo
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1. Study Identification

Unique Protocol Identification Number
NCT03497650
Brief Title
Unilateral Strength Training and Mirror Therapy for Chronic Stroke Patients
Official Title
Unilateral Strength Training and Mirror Therapy for Enhancing Lower Limb Motor Function Post Stroke: A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 22, 2014 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Technology, Sligo

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot Randomised Controlled Trial
Masking
Outcomes Assessor
Masking Description
Outcome assessor only was masked.
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror Therapy + Cross-Education.
Arm Type
Experimental
Arm Description
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.
Arm Title
Cross-Education of Strengthening.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mirror Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cross-Education of Strengthening.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal Isometric ankle dorsiflexion Strength.
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS).
Description
Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension).
Time Frame
10 minutes.
Title
Timed Up and Go (TUG).
Description
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.
Time Frame
5 minutes.
Title
10 Metre Walk Test (10MWT).
Description
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.
Time Frame
5 minutes.
Title
London Handicap Scale (LHS).
Description
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'.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Simpson, PhD
Organizational Affiliation
IT Sligo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Technology, Sligo
City
Sligo
State/Province
Co Sligo
ZIP/Postal Code
F91YW50
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD is shared with any other researchers.

Learn more about this trial

Unilateral Strength Training and Mirror Therapy for Chronic Stroke Patients

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