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Upper Extremity Orthoses Combined With Occupational Therapy in Subacute Stroke

ConditionStroke (Subacute)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Western Macedonia

About this trial

This randomized controlled trial will investigate whether static or dynamic hand orthoses used as adjuncts to occupational therapy improve upper extremity recovery in adults with subacute stroke. Participants will be randomly assigned to one of three parallel groups: conventional occupational therapy alone, occupational therapy combined with a dynamic hand orthosis, or occupational therapy combined with a static hand orthosis. All groups will receive a standardized occupational therapy program for 4 weeks. Participants in the two orthosis groups will additionally use the assigned orthosis for 120 minutes per day, 5 days per week, following the occupational therapy session. Clinical outcomes will be assessed at baseline, at the end of the 4-week intervention, and at 8 weeks from the start of the intervention. The primary outcome will be upper extremity motor function assessed with the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

First-ever stroke confirmed by CT or MRI (ischemic or hemorrhagic).

Time since stroke: from Day 8 to 6 months (subacute phase of recovery).

Presence of motor impairment in the affected upper extremity.

Disqualifiers

Previous stroke.

Other significant neurological disorder affecting upper extremity function (e.g., Parkinson disease, multiple sclerosis, peripheral neuropathy).

Severe upper extremity spasticity (MAS = 4).

Severe cognitive impairment (MoCA <11).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standardized Occupational Therapy

    Behavioral

    A standardized, individualized occupational therapy program focused on upper extremity rehabilitation. Treatment may include mobilization, motor control training, hand function activities, muscle activation and strengthening, task-oriented functional activities, activities of daily living, sensory retraining when clinically indicated, and motor learning strategies. Sessions will last 45 minutes and will be delivered 5 days per week for 4 weeks, for a planned total of 20 sessions.

  • Dynamic Hand Orthosis

    Device

    A dynamic hand orthosis used as an adjunct to the standardized occupational therapy program. The orthosis will be worn for 120 minutes per day, 5 days per week for 4 weeks, following completion of the occupational therapy session. Adherence, tolerance, and safety related to orthosis use will be monitored throughout the intervention period.

  • Static Resting Hand Orthosis

    Device

    A commercially available static resting hand orthosis (VITA Orthopaedics Resting Hand Orthosis 03-2-005) used as an adjunct to the standardized occupational therapy program. The orthosis will be worn for 120 minutes per day, 5 days per week for 4 weeks, following completion of the occupational therapy session. Adherence, tolerance, and safety related to orthosis use will be monitored throughout the intervention period.

Treatment groups

102 Participants
are divided into 3 treatment groups
Group A: Occupational Therapy AloneActive comparator 1 intervention
Group B: Occupational Therapy Plus Dynamic Hand OrthosisExperimental treatment 2 interventions
Group C: Occupational Therapy Plus Static Hand OrthosisExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)

Upper extremity motor function will be assessed using the FMA-UE, which evaluates motor impairment and recovery of the affected upper extremity after stroke. The total FMA-UE motor score ranges from 0 to 66, with higher scores indicating better motor function.

Time frame
Baseline, Week 4, and Week 8

Secondary outcomes

1

Modified Ashworth Scale (MAS)

Muscle tone of the affected upper extremity will be assessed using the MAS, focusing on the finger flexors. Scores range from 0 to 4, with higher scores indicating greater muscle tone/spasticity.

Time frame
Baseline, Week 4, and Week 8
2

Medical Research Council Scale (MRC) - Finger Flexion

Muscle strength of the finger flexors of the affected hand will be assessed using the MRC Scale. Strength will be graded from 0 to 5, with higher scores indicating greater muscle strength. The finger flexion score will be recorded and analyzed separately from the finger extension score.

Time frame
Baseline, Week 4, and Week 8
3

Medical Research Council Scale (MRC) - Finger Extension

Muscle strength of the finger extensors of the affected hand will be assessed using the MRC Scale. Strength will be graded from 0 to 5, with higher scores indicating greater muscle strength. The finger extension score will be recorded and analyzed separately from the finger flexion score.

Time frame
Baseline, Week 4, and Week 8
4

Hand Dynamometer (JAMAR)

Grip strength of the affected hand will be measured using a JAMAR hand dynamometer. Three maximal grip attempts will be performed, and the mean value of the three measurements will be recorded in kilograms. Higher values indicate greater grip strength.

Time frame
Baseline, Week 4, and Week 8

Other outcomes

Sponsors and contacts

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University of Western Macedonia

Lead sponsor

ANAGENNISI Recovery and Rehabilitation Center of Thessaloniki

Collaborator

Source ClinicalTrials.gov

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