tSCS + UL Robotics Training in SCI Patients
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorNational University Hospital, Singapore
About this trial
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluates the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 to 8 subjects with C2-8 level injuries will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks.
Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1, Post-Phase 2, and 4 weeks Follow-up. A satisfaction survey on the intervention "ULRT training + tSCS + conventional physiotherapy" will be performed at end of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 6 months to 5 years from the diagnosis of the traumatic SCI;
Participants between 21 and 80 years of age;
C2-8 level injuries;
ISNCSCI-UEMS >25,
Disqualifiers
Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator.
Participant has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound performance and outcomes like uncontrolled neuropathic pain, depression, severe cognitive impairment.
Unstable or uncontrolled autonomic dysreflexia.
Requires ventilator support.
Trial design
Design model
Crossover
Treatments tested in this trial
ULRT + tSCS + conventional occupational therapy
DeviceSubject will undergo 16 sessions of Upper limb robotics training (ULRT) + tSCS+ conventional occupational therapy, 2 sessions a week for 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist based on their assessment. During tSCS, cathodes will be placed on the T11 and L1 spinous process. Reference/Ground electrodes placed over the ASIS. It will be on biphasic mode with a stimulation delivered at 30-50 Hz with a 10-kHz carrier frequency overlay, which consisted of 10 pulses with a 10-kHz frequency and 100-µs pulse width.Stimulation intensity ranges from 5-100 mA and will be adjusted according to the patient's response.The tSCS stimulation duration for each session will be 45 minutes in conjunction with the ULRT training.
ULRT + conventional occupational therapy
DeviceParticipants will undergo 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist based on their assessment.
Treatment groups
6 Participants
are divided into 2 treatment groupsGroup A: ULRT+ conventional occupational therapyActive comparator 1 intervention
Group B: ULRT + tSCS + conventional occupational therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
GRASSP 2
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
Time frame
Week 02
GRASSP 2
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
Time frame
Week 83
GRASSP 2
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
Time frame
Week 164
GRASSP 2
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
Time frame
Week 20Secondary outcomes
1
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.
Time frame
Week 02
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.
Time frame
Week 83
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.
Time frame
Week 164
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.
Time frame
Weeks 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National University Hospital, Singapore
Lead sponsor
Alexandra Hospital
Collaborator
Source ClinicalTrials.gov