Mirror Therapy with Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in Stroke

NCT03622879 | Recruiting

• 1 other identifier: 2018_GRF_NG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of concurrent mirror therapy (MT) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that MT combined with TENS would be superior to sham-mirror therapy with TENS, or MT with placebo-TENS, or control training only in improving lower limb motor functions and walking ability in people with stroke when combined with the lower limb task-oriented training.

Conditions

Stroke

Keywords

Mirror therapy; Transcutaneous Electric Nerve Stimulation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE)

  FMA-LE is used to evaluate the lower extremity motor control, including reflexes, voluntary control of isolated movement and coordination. The scale score ranging from 0 to 34, with 17 items and ordinal scoring from 0 to 2. A higher score indicates a better lower extremity motor control. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).

  Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

Secondary Outcomes (6)

• The Change of Paretic ankle dorsiflexor strength

  Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

• The Change of Paretic ankle plantarflexor strength

  Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

• The Change of 10-m walk test

  Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

• The Change of Timed 'Up and Go' test

  Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

• The Change of Lower-extremity motor co-ordination test

  Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

Study Arms (4)

MT + TENS

EXPERIMENTAL

The subject will adopt a semi-seated position on a bed while the mirror board is positioned between the legs perpendicular to the subject's midline. The paretic leg will be positioned behind the mirror, with the intact leg facing the reflective surface. All subjects will be reminded to focus on the image in the mirror during MT training. All subjects will receive concurrent TENS stimulation over the common peroneal nerve while practising bilateral lower limb exercises. After 15 minutes of priming with TENS + MT, all subjects will perform 60 minutes of lower limb task-oriented training.

Behavioral: MT; Device: TENS; Behavioral: Lower-limb task-oriented training

Placebo-MT+TENS

PLACEBO COMPARATOR

In the Placebo-MT+TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group, except that the reflecting surface of the angle-adjustable mirror was covered with paper. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training.

Device: TENS; Behavioral: Lower-limb task-oriented training

MT+placebo-TENS

PLACEBO COMPARATOR

In the MT+placebo-TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group. The only difference is that placebo stimulation will be applied to the paretic limb from identical-looking TENS devices with the electrical circuit disconnected inside. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training.

Behavioral: MT; Behavioral: Lower-limb task-oriented training

control training

SHAM COMPARATOR

All subjects will perform 60 minutes of lower limb task-oriented training only.

Behavioral: Lower-limb task-oriented training

Interventions

MT BEHAVIORAL

A customised angle-adjustable frame with a mirror board (60 × 90 cm) will be used. All subjects are instructed to perform hip flexion/abduction, knee flexion/extension and ankle dorsiflexion/plantarflexion on the intact-limb during a 15 minutes period.

MT + TENS; MT+placebo-TENS

TENS DEVICE

TENS will be delivered to the common peroneal nerve of the paretic leg. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold.

MT + TENS; Placebo-MT+TENS

Lower-limb task-oriented training BEHAVIORAL

The lower-limb task-oriented training comprises 6 exercises, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, kicking a ball with alternate legs, gait re-education and transition training. Each exercise last for 10 minutes

MT + TENS; MT+placebo-TENS; Placebo-MT+TENS; control training

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have had a single stroke with ischemic brain injury or intracerebral haemorrhage diagnosed by magnetic resonance imaging or computed tomography within the previous 6 to 36 months;
• have at least 5 degrees of active ankle dorsiflexion in the antigravity position;
• are able to walk 10 m independently with or without a walking aid;
• are able to score 6 or higher out of 10 on the abbreviated mental test;
• have no unilateral neglect, hemianopia or apraxia;
• have no skin allergy (e.g. redness or itchiness to the electrical stimulation pads) to electrical stimulation or electrodes; and
• are able to follow instructions and give informed consent.

You may not qualify if:

• have any additional medical, cardiovascular or orthopaedic condition that would hinder proper treatment or assessment;
• have visual deficits that may hinder them from benefiting from the mirror visual feedback;
• have receptive dysphasia; or
• are involved in drug studies or other clinical trials.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• SSM Ng, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SSM Ng, PhD

CONTACT

+852 2766-4889; shamay.ng@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 9, 2018
• Study Start: July 2, 2018
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

HK (1)