About this trial
The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). As secondary aims, the study will also investigate at how this combination approach affects the cortical changes in the somatosensory and motor areas of the brain, as well as in the spinal cord and whether it helps participants use their arms more in daily life.
The main questions relevant to this study are:
1. Can the combination of ABT + tSCS improve motor and sensory functions of the arms and hands more than ABT alone during the sub-acute stage after SCI? 2. Does ABT + tSCS induce neuroplasticity, that is, changes in the brain and spinal cord activity linked to motor and sensory functions? 3. Do participants who receive ABT + tSCS report greater use of their arms in daily activities compared to those who receive ABT only?
In this study, participants will:
* Receive either ABT + tSCS or ABT + sham stimulation (a low-intensity current that does not facilitate the movements) * Take part in 20 training sessions over 6-8 weeks (3 times per week, 45 min of active training each). During this, they will perform strengthening, task-based training, and motor control strengthening exercises with a therapist. * Complete clinical tests and neurophysiological assessments (transspinal electrical stimulation, electroencephalography and transcranial magnetic stimulation) at three time points-- at the start, after training, and one month later to measure recovery and brain activity changes.
Researchers will compare the assessment outcomes across the three time points.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Traumatic and non-traumatic spinal cord injury
Receiving in-patient rehabilitation
16 years old or above
American Spinal Injury Association (ASIA) grade A to D
Disqualifiers
Cardiac pacemaker
Active cancer at the stimulation site or metastatic cancer
Unstable lesion or clinical condition (e.g. respiratory issues)
Electrode placement is impossible due to unhealed wound or significant local pain
Trial design
Parallel
Treatments tested in this trial
Protocol 1: Combination of activity-based therapy and sham spinal cord stimulation
Other interventionThe training session for the sham group comprises of activity-based therapy along with sham stimulation on the spinal cord of the participants. These training sessions will include repetitive, intensive strength training and functional exercises targeting arm and hand (upper limb) movements. Sessions will be delivered by trained physiotherapists and occupational therapists. Each participant will complete 20 sessions over six to eight weeks (three per week), with each session lasting 45 minutes. Breaks will be added, if needed. Training will consist of cardiovascular training, stretching, weight-bearing, strengthening and controlled strengthening and task-oriented training. Participants will receive transcutaneous spinal cord stimulation set at sensory threshold intensity (i.e., below the threshold that facilitates voluntary movement of the limb; usually 2-3 mA intensity), delivered simultaneously with training.
Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation
Other interventionThe training session for the experimental group comprises of activity-based therapy along with facilitatory stimulation on the spinal cord of the participants. These training sessions will include repetitive, intensive strength training and functional exercises targeting arm and hand (upper limb) movements. Sessions will be delivered by trained physiotherapists and occupational therapists. Each participant will complete 20 sessions over six to eight weeks (three per week), with each session lasting 45 minutes. Breaks will be added, if needed. Training will consist of cardiovascular training, stretching, weight-bearing, strengthening and controlled strengthening and task-oriented training. Participants will receive transcutaneous spinal cord stimulation set at a target intensity that facilitates voluntary upper limb movement (usually between 10 and 25 mA) in the participants.
Treatment groups
Trial outcomes
Primary outcomes
Upper Extremity Motor Score (UEMS)
This will be used for assessing the motor function, that is, the strength and functionality of the muscles involved in movement. It helps determine the severity of motor impairments in patients with cervical lesions and is used to track recovery and assess outcome during inpatient rehabilitation. It has high inter-rater and intra-rater reliability. It also has high validity as an impairment measure and has moderate validity for predicting real-world functional independence. The test evaluates five movements of each arm, namely, elbow flexion, wrist extension, elbow extension, middle finger flexion, and little finger abduction. The participant is asked to perform these movements either actively or passively, depending on their ability. These are scored on a scale from 0 (no movement) to 5 (full function). Thus, the higher score reflects improvement in the motor function across the three time frames.
Secondary outcomes
The Prehension subtest of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP- version 2)
This test will be used to assess the hand function in participants, particularly their grasping ability and object manipulation. This includes two components: prehension ability (PA) and prehension performance (PP). PA evaluates the capacity to perform different grasp patterns, including cylindrical, lateral pinch, and tip pinch grasps. Each hand is assessed separately and scored on a scale from 0 to 4, with 4 being the normal voluntary control of the wrist and fingers during grasp execution. PP assesses the ability to complete functional tasks requiring grasp, manipulation, and release of objects of various shapes and sizes. Each hand is evaluated separately, and task performance is scored from 0 to 5, with 5 being the most successful task completion using the intended grasp pattern. Higher total scores indicate better hand function and prehension ability. The subtest has excellent test-retest reliability (ICC = 0.93-0.98) and excellent inter-rater reliability (ICC = 0.95-0.96).
Upper-limb sensory score of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
This will be used to assess the sensory level of the participant by evaluating the ability to feel stimuli and to differentiate between sharp and dull sensations (pinprick test) on specific regions of the skin corresponding to spinal nerve segments. The summed sensory scores (light touch + pinprick) have good to excellent inter- and intra-rater reliability. So, we will use the summed scores. The test has good validity for classifying lesion level and severity, moderate for predicting function, and has limited sensitivity (not sensitive to subtle changes) compared to electrophysiological or quantitative tests. Light touch and pinprick sensation are first demonstrated on the participant's cheek. The participant, seated with eyes closed, is tested using light touch with tissue or cotton (assessing large A fibers) and pinprick with a pin or toothpick (assessing smaller A-delta and C fibers for superficial pain) at six test sites. The sensation is reported by them.
Monofilament test
This will be used to quantify and to assess the sensory function, particularly for detecting areas of sensory loss or abnormal sensation (neuropathic pain). This test has high validity and inter-and intra tester reliability in participants with chronic cervical spinal cord injury. The test is conducted using Semmes-Weinstein monofilaments. With eyes closed, the participant is asked to report whether they can feel the pressure when a monofilament is applied to different regions of the upper limb. The threshold at which the stimulus is perceived is recorded (5.88, 5.07, 4.56, 4.08, 3.22). Specific regions are assessed depending on the nerve: the pulp of the middle finger for the median nerve, the pulp of the little finger for the ulnar nerve, the first dorsal space of the hand between the thumb and index finger and the lateral epicondyle at the extensor compartment for the radial nerve, and the deltoid region for the axillary nerve.
Force (Grip and Pinch Strength) test
This will be used to assess grip and pinch strength which are used in daily tasks involving hand function. The Pinch strength test has good to excellent reliability for neurological conditions and has strong to very strong correlations with grip strength. It has a good validity. The Grip strength has an excellent test-retest reliability in SCI. It shows a very high intra- and inter-rater reliability if standardized protocols (same dynamometer, position, instructions) are followed. It has a good validity. Grip strength is measured using a dynamometer, with the participant seated and the elbow flexed at 90 degrees. The participant must squeeze the device as hard as possible for 3 trials; the average of these trials is calculated. Pinch strength is measured using a pinch gauge, where the participant pinches an object between the thumb and index finger with maximum effort. Again, the average of 3 trials is taken.
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