Tetraplegia/TetraparesisTRRATNCT07860827
Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia
A study testing Robotic Rehabilitation with PABLO® and Standard Gym Rehabilitation in people with Tetraplegia/Tetraparesis and Rehabilitation Treatment, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of upper-limb robotic rehabilitation training (PABLO®) for recovering muscle strength in the scapulohumeral region and the proximal upper limb-compared to standard rehabilitation treatment alone-in male and female patients aged 18 to 80 years with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tetraplegia/Tetraparesis, Rehabilitation Treatment, Gaining Skeletal Muscle Mass and Strength
- What is being tested?
- Robotic Rehabilitation with PABLO® and Standard Gym Rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 31 Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PRIMARY
- The investigator obtains the patient's informed consent to participate in the clinical trial and to the processing of personal data.
- Tetraplegic/tetraparetic patients with spinal cord injury of various etiologies (traumatic, ischemic, infectious, etc.) as defined by the ASIA Impairment Scale, who are capable of movements at least against gravity-even with a partial range of motion (MRC ≥2/5)-in the muscles of the scapulohumeral region and the elbow on at least one side of the body.
- Age ≥ 18 years and ≤ 80 years.
- Time interval between the acute event and study enrollment not exceeding 120 days.
- SECONDARY
- Ability to maintain a seated position in a non-reclined wheelchair (trunk-pelvis angle of 90°) for one hour.
- Improvement in strength of ≥ 1 point (out of 5) on the MRC scale in less than half of the upper limb regions assessed at Visit V1.
Who cannot join
- ASIA with a neurological level of C2 or higher.
- Previous cerebrovascular events, neurodegenerative disorders, or spinal cord injuries that have resulted in motor and/or cognitive impairment.
- History of major psychiatric disorders.
- Concurrent traumatic brain injury during the acute phase.
- Previous orthopedic conditions of the shoulder resulting in severe functional impairment.
- Active rheumatological conditions.
- Severe uncorrected visual impairment (such that it prevents the patient from viewing the computer-based exercises proposed by the robot).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria Hospital
Negrar, Veneto, 37024
Elena Rossato, Dr.ssa, +39 045.6014597, elena.rossato@sacrocuore.it
About this study
Official title: Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia (TRRAT): A Pilot, Multicenter, Randomized Controlled Trial
The goal of this clinical trial is to evaluate the efficacy of upper-limb robotic rehabilitation training (PABLO®) for recovering muscle strength in the scapulohumeral region and the proximal upper limb-compared to standard rehabilitation treatment alone-in male and female patients aged 18 to 80 years with tetraplegia/tetraparesis due to spinal cord injury of various etiologies (traumatic, ischemic, infectious, etc.) in the subacute phase.
Read the detailed description
The rehabilitation protocol includes:
- 2 weeks of standard upper limb gym rehabilitation treatment;
Randomization of patients into two treatment groups (lasting 3 weeks):
- Arm A, undergoing upper-limb treatment solely with a robotic device;
- Arm B, undergoing only standard physiotherapy treatment
For the evaluation of neurological assessment of motor and sensory functions will be used the American Spinal Injury Association (ASIA) Impairment Scale.
Specifically, the assessment of muscle strength of proximal muscles of the upper limb and the scapulohumeral region will be used the Medical Research Council (MRC) scale.
The enrollment evaluation (V0) consists of a physiatric examination, including an assessment of motor function and muscle strength in the scapulohumeral region and the proximal portions of the upper limbs, as well as any sensory deficits in the upper limbs, followed by determination of the neurological level of injury and classification according to the ASIA Impairment Scale. After two to four weeks of hospitalization, during which the patient undergoes standard rehabilitation, the examiner reevaluates the patient (V1).
After two weeks of standard upper-limb rehabilitation, the patient undergoes a further clinical reevaluation (V2) and is subsequently randomized into two treatment groups: Arm A (experimental arm) or Arm B (standard control arm). At the end of this training period, the patient will be re-evaluated (V3) by the same examiner who conducted the V1 visit and who will be blinded to the rehabilitation treatment received by the patient (the patient will be asked not to disclose the type of rehabilitation performed).
- Conditions
- Tetraplegia/Tetraparesis, Rehabilitation Treatment, Gaining Skeletal Muscle Mass and Strength
- Being tested
- Robotic Rehabilitation with PABLO®, Standard Gym Rehabilitation
- Keywords
- tetraplegia/tetraparesis, rehabilitation training, PABLO®
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Rehabilitation with PABLO®Device
3 weeks of robotic rehabilitation treatment with PABLO®, consisting of 15 rehabilitation sessions, each lasting 1 hour, for the upper limbs, focused on restoring strength and motor function.
Treatments involve one-dimensional (lateral-lateral or anteroposterior) and two-dimensional active mobilization of the upper extremities using the PABLO® Multiboard, a device that secures the hand and wrist with a handle and allows for flexion and extension movements of the elbow and shoulder.
Standard Gym RehabilitationProcedure or surgery
3 weeks of standard rehabilitation treatment, consisting of 15 rehabilitation sessions in the gym (5 per week for 3 consecutive weeks), each lasting 1 hour. Treatments are designed to maintain or restore range of motion in the shoulder joint through passive, active-assisted, and active mobilization exercises guided by the physical therapist, strength training of the proximal muscles of the upper limb, electrostimulation of the proximal muscles of the upper limb and use of physical therapies for analgesic and anti-inflammatory purposes.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Rehabilitation with PABLO® | Experimental | Not described Receives: Device: Robotic Rehabilitation with PABLO® |
| Standard Rehabilitation | Active comparator | Not described Receives: Procedure: Standard Gym Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological assessment of motor function and sensation
Neurological assessment of motor function and sensation using the American Spinal Injury Association (ASIA) Impairment Scale. Assessment of muscle strength using the Medical Research Council (MRC) scale for the proximal muscles of the upper limb and the scapulohumeral region (flexion-extension, abduction/adduction, internal and external rotation of the shoulder, and flexion-extension of the elbow), administered both before and after treatment.
Measured: From enrollment (Visit 0) to Visit 3 (7-9 weeks after Visit 0)
Secondary outcomes (6)
Passive Range of Motion (pROM)
Passive Range of Motion (pROM) at the scapulohumeral joint across various planes of motion (flexion-extension, abduction/adduction, internal and external rotation of the shoulder, and flexion-extension of the elbow), measured both pre- and post-treatment
Measured: From enrollment (Visit 0) to Visit 3 (7-9 weeks after Visit 0)
Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) for assessing shoulder pain, recorded at all visits, both pre- and post-treatment;
Measured: From Visit 1 (2-4 weeks after Visit 0) to Visit 3 (7-9 weeks after Visit 0)
Spinal Cord Independence Measure (SCIM-III) scale
Spinal Cord Independence Measure (SCIM-III) scale, measured both pre- and post-treatment
Measured: From enrollment (Visit 0) to Visit 3 (7-9 weeks after Visit 0)
number of sessions required before beginning 2D exercises
number of sessions required before beginning 2D exercises
Measured: At Visit 2 (4-6 weeks after Visit 0) and Visit 3 (7-9 after Visit 0)
Wheelchair Skills Test Italian Version 4.3 Powered Mobility Devices (WST-I 4.3 PMD)
Wheelchair Skills Test Italian Version 4.3 Powered Mobility Devices (WST-I 4.3 PMD), measured pre- and post-treatment
Measured: At Visit 2 (4-6 weeks after Visit 0) and Visit 3 (7-9 after Visit 0)
Modified Physical Therapy Patient Satisfaction Questionnaire (PTPSQ-1 mod)
Modified Physical Therapy Patient Satisfaction Questionnaire (PTPSQ-1 mod), completed during the final visit
Measured: At Visit 3 (7-9 weeks after Visit 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Apr 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetraplegia/TetraparesisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860827
- Sponsor's protocol ID
- 2023-23
- Acronym
- TRRAT
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No