Stroke (Subacute)NCT07864090
Upper Extremity Orthoses Combined With Occupational Therapy in Subacute Stroke
A study testing Standardized Occupational Therapy, Dynamic Hand Orthosis and Static Resting Hand Orthosis in people with Stroke (Subacute), run by University of Western Macedonia at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke (Subacute)
- What is being tested?
- Standardized Occupational Therapy, Dynamic Hand Orthosis and Static Resting Hand Orthosis
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Modified Ashworth Scale (MAS) score of 0-3 in the affected upper extremity.
- Montreal Cognitive Assessment (MoCA) score ≥11.
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- Ability to understand and follow simple one- to two-step commands.
- Ability to remain seated for approximately 45 minutes.
- Clinically stable condition.
- Provision of written informed consent
Who cannot join
- 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).
- Absence of upper extremity motor impairment.
- Severe orthopedic condition or anatomical deformity of the affected upper extremity that substantially limits passive movement or safe orthosis application.
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- Unstable clinical condition.
- Severe pain in the affected upper extremity that limits movement and/or safe orthosis application (VAS ≥75/100 or pain that restricts passive movement/orthosis fitting).
- Inability to remain seated for approximately 45 minutes.
- Severe or uncontrolled psychiatric disorder affecting safety or cooperation.
- Skin lesions, ulcers, or other conditions of the affected upper extremity that preclude safe orthosis use.
- Botulinum toxin type A injection in the affected upper extremity within the previous 4 months or a planned injection during the study period.
- Inability to cooperate with or adhere to the study protocol.
- Participation in another clinical trial or recent intervention that may influence study outcomes.
- Inability to provide valid informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ioannis Ventoulis, PhD contact
Greece1 site
ANAGENNISI Recovery and Rehabilitation Center of Thessaloniki
Thermi, Central Macedonia, 57001
Georgios Kalogirou, MSc, +30 6988787885, dot00005@uowm.gr
Georgios Kalogirou, Msc
About this study
Official title: Static and Dynamic Hand Orthoses as Adjuncts to Occupational Therapy for Upper Extremity Recovery After Subacute Stroke: A Randomized Controlled 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).
Read the detailed description
The study is a prospective, randomized, controlled, assessor-blinded, three-arm parallel-group clinical trial involving adults with subacute stroke undergoing inpatient rehabilitation. Its objective is to evaluate the effects of static and dynamic hand orthoses used as adjuncts to a standardized occupational therapy program for upper extremity rehabilitation.
Following baseline assessment, eligible participants will be randomly allocated to one of three groups: occupational therapy alone, occupational therapy combined with a dynamic hand orthosis, or occupational therapy combined with a static hand orthosis. All participants will receive a standardized occupational therapy program consisting of 45-minute sessions, 5 days per week for 4 weeks, for a planned total of 20 sessions.
The occupational therapy program will follow a common therapeutic framework across all groups and will be individualized according to each participant's motor and functional status. Treatment may include upper extremity 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.
Participants allocated to either orthosis group will additionally use the assigned hand orthosis for 120 minutes per day, 5 days per week for 4 weeks, following the occupational therapy session. Adherence, tolerance, and safety related to orthosis use will be monitored throughout the intervention period.
Outcome assessments will be conducted by independent assessors blinded to group allocation at baseline, at Week 4, immediately following completion of the intervention, and at Week 8 from the start of the intervention. The primary outcome will be upper extremity motor function assessed using the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE). Secondary outcomes will include muscle tone, muscle strength, grip strength, gross manual dexterity, functional independence in activities of daily living, and pain.
- Conditions
- Stroke (Subacute)
- Being tested
- Standardized Occupational Therapy, Dynamic Hand Orthosis, Static Resting Hand Orthosis
- Keywords
- Occupational Therapy, Upper Extremity Rehabilitation, Hand Orthoses, Subacute Stroke, Motor Recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Occupational TherapyBehavioural
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 OrthosisDevice
Also called Aurafix ORT-07A Thermoplastic Dynamic Splint
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 OrthosisDevice
Also called VITA Orthopaedics Resting Hand Orthosis 03-2-005
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.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy Alone | Active comparator | Participants will receive a standardized occupational therapy program consisting of 45-minute sessions, 5 days per week for 4 weeks, for a planned total of 20 sessions. No upper extremity orthosis will be used as part of the study intervention. Receives: Behavioral: Standardized Occupational Therapy |
| Occupational Therapy Plus Dynamic Hand Orthosis | Experimental | Participants will receive the same standardized occupational therapy program as the control group and will additionally use a dynamic hand orthosis for 120 minutes per day, 5 days per week for 4 weeks, following the occupational therapy session. Receives: Behavioral: Standardized Occupational Therapy; Device: Dynamic Hand Orthosis |
| Occupational Therapy Plus Static Hand Orthosis | Experimental | Participants will receive the same standardized occupational therapy program as the control group and will additionally use a static hand orthosis for 120 minutes per day, 5 days per week for 4 weeks, following the occupational therapy session. Receives: Behavioral: Standardized Occupational Therapy; Device: Static Resting Hand Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (7)
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
Box and Block Test (BBT)
Gross manual dexterity of the affected upper extremity will be assessed using the BBT. The outcome will be the number of blocks successfully transferred over the partition within 60 seconds. Higher scores indicate better gross manual dexterity.
Measured: Baseline, Week 4, and Week 8
Modified Barthel Index (MBI)
Functional independence in activities of daily living will be assessed using the MBΙ. The total score ranges from 0 to 100, with higher scores indicating greater functional independence.
Measured: Baseline, Week 4, and Week 8
Visual Analogue Scale (VAS)
Pain intensity in the affected upper extremity will be assessed using a 100-mm VAS, ranging from 0 to 100, where 0 indicates no pain and 100 indicates the maximum perceived pain. The anatomical location of pain will also be recorded when pain is present.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (Subacute)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: occupational therapy alone, occupational therapy combined with a dynamic hand orthosis, or occupational therapy combined with a static hand orthosis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Macedonia
- Sponsor type
- University, hospital or other
- Collaborators
- ANAGENNISI Recovery and Rehabilitation Center of Thessaloniki
- Responsible party
- Sponsor
- Investigators
- Georgios Kalogirou, MSc, Principal investigator, University of Western MacedoniaIoannis Ventoulis, PhD, Study chair, University of Western Macedonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864090
- Sponsor's protocol ID
- UOWM-OT-ORTH-STROKE-01
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers because the study protocol does not include a predefined data-sharing plan. Participant data will be pseudonymized and used exclusively for the purposes of this doctoral research, in accordance with the approved protocol, institutional requirements, and applicable data protection regulations.