Health Trials

Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After Stroke

ConditionsStrokeHemiplegiaUpper Limb Motor Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Baghdad

About this trial

Post-stroke hemiplegia frequently results in impaired upper limb function, which significantly affects independence and quality of life. Various rehabilitation approaches have been developed to improve motor recovery, including mirror therapy and robotic-assisted training. Mirror therapy uses visual feedback to stimulate neural plasticity and enhance motor recovery, while soft robotic gloves assist repetitive hand movements and facilitate functional training.

This randomized controlled trial aims to investigate the effect of combining mirror therapy with a soft robotic glove on hand function recovery in patients with post-stroke hemiplegia. Participants will be randomly assigned to different intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation.

The primary outcome will assess improvement in upper limb motor function using validated clinical assessment tools. Secondary outcomes will evaluate functional hand performance and activities of daily living. The findings of this study may contribute to improving rehabilitation strategies for stroke survivors and provide evidence for integrating innovative rehabilitation technologies into clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Rehabilitation

    Other intervention

    Standard rehabilitation therapy focused on improving upper limb function in individuals with stroke

  • Mirror Therapy

    Other intervention

    A rehabilitation technique using a mirror to create a visual illusion of movement in the affected limb to improve motor recovery after stroke.

  • Soft Robotic Glove

    Device

    A wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke

  • Mirror Therapy plus Soft Robotic Glove

    Combination product

    Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training

Treatment groups

104 Participants
are divided into 4 treatment groups
Group A: Conventional RehabilitationActive comparator 1 intervention
Group B: Mirror TherapyExperimental treatment 1 intervention
Group C: Soft Robotic Glove TrainingExperimental treatment 1 intervention
Group D: Mirror Therapy plus Soft Robotic GloveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Upper Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)

Assesses motor recovery of the affected upper limb following stroke, including voluntary movement, coordination, and reflex activity using a standardized stroke-specific motor scale. Scores range from 0 to 66, with higher scores indicating better motor recovery and motor performance.

Time frame
Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up.
2

Functional Use of Affected Limb (Functional Test of Upper Limb Hemiplegia - Hong Kong, FTHUE-HK)

Evaluates functional use of the affected upper limb in individuals with hemiplegia through hierarchical task performance. Scores range from Level 1 (no active movement) to Level 7 (advanced functional hand use), with higher levels indicating greater functional recovery.

Time frame
Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up

Secondary outcomes

Other outcomes

1

Activities of Daily Living (Katz Index of Independence in ADL)

Measures the participant's ability to independently perform six basic self-care activities including bathing, dressing, toileting, transferring, continence, and feeding. Scores range from 0 to 6, with higher scores indicating greater independence in activities of daily living.

Time frame
Baseline, 4 weeks, post-intervention, 3-month follow-up
2

Upper Limb Spasticity (Modified Ashworth Scale, MAS)

Assesses muscle spasticity in the affected upper limb by grading resistance during passive soft-tissue stretching. Scores range from 0 to 4, where higher scores indicate increased muscle tone and greater spasticity.

Time frame
Baseline, 4 weeks, post-intervention, 3-month follow-up
3

Cognitive Screening (Six-Item Cognitive Impairment Test, 6CIT)

A brief screening tool used to assess cognitive status prior to study participation, including orientation, memory, and attention. Scores range from 0 to 28, with higher scores indicating greater cognitive impairment.

Time frame
Baseline
4

Visual Acuity (Snellen Chart)

Evaluates visual acuity to ensure participants can adequately perform mirror-based visual feedback during therapy. Visual acuity is measured using the standard Snellen fraction (e.g., 6/6 to 6/60), where better vision corresponds to higher visual acuity.

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov
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