Clinical trial NCT03497650: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Institute of Technology, Sligo
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Randomised Controlled Trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximal Isometric ankle dorsiflexion Strength.
timeFrame: 10 minutes
Secondary outcomes:
measure: Modified Ashworth Scale (MAS).
timeFrame: 10 minutes.
measure: Timed Up and Go (TUG).
timeFrame: 5 minutes.
measure: 10 Metre Walk Test (10MWT).
timeFrame: 5 minutes.
measure: London Handicap Scale (LHS).
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Sligo
country: Ireland
facility: Institute of Technology, Sligo
state: Co Sligo
Study officials:
affiliation: IT Sligo
name: Daniel Simpson, PhD
role: PRINCIPAL_INVESTIGATOR
References: