This pilot randomized clinical trial enrolled 16 adults with spinal cord injury to compare Cognitive Multisensory Rehabilitation (CMR) against adaptive fitness as a comparator. The study assessed sensorimotor function and neuropathic pain as primary outcomes, with brain activity and connectivity as secondary outcomes, over a 3-month follow-up period. The setting was not reported.
For the CMR group, improvements were observed across multiple measures with large effect sizes: ASIA touch (d=1.54), ASIA pinprick (d=1.83), ASIA lower limb motor function (d=1.32), Neuromuscular Recovery Scale (NRS) core (d=2.19), NRS upper limb (d=0.69), and NRS lower limb (d=0.74). The adaptive fitness group showed smaller improvements on NRS measures: core (d=0.73), upper limb (d=0.34), and no change in lower limb function (d=0.00). All comparisons indicated greater effects for CMR than adaptive fitness.
Safety and tolerability data were not reported in the provided evidence. Key limitations include the very small sample size of 16 participants, the pilot nature of the trial, and the absence of p-values or confidence intervals to assess statistical significance. The publication type was also not reported.
For clinical practice, these findings suggest CMR may be a promising rehabilitation approach for improving sensorimotor function in spinal cord injury patients. However, the evidence remains preliminary due to the small scale and pilot design. Clinicians should interpret these results cautiously while awaiting larger, confirmatory trials with more robust statistical reporting.
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IntroductionAdults with spinal cord injury (SCI) often experience reduced or lost sensation and movement, impairing the ability of the brain to locate paralyzed body parts, which, in turn, compromises sensorimotor recovery. This disruption of the internal body map of the brain, or mental body representations (MBR), also contributes to neuropathic pain in about 69% of adults with SCI. Medications for neuropathic pain are often ineffective and can cause adverse reactions. Our previous pilot clinical trial showed that Cognitive Multisensory Rehabilitation (CMR), a physical therapy that restores MBR, produced significant, lasting reductions in neuropathic pain, improved sensorimotor function, and enhanced brain function. Building on these results, we examined whether 8 weeks of CMR or adaptive fitness (1) improved sensorimotor function and reduced pain; (2) greater brain activity and connectivity related to sensorimotor function and MBR in adults with SCI.
MethodsSixteen participants (52+/-8 years old, 13+/-10 years post-SCI) were randomized to 8 weeks of CMR or adaptive fitness (45 min, 3x/week). Ten participants had neuropathic pain of 3/10 or greater. Pain and sensorimotor function were assessed at baseline, post-intervention, and 3-month follow-up using the Numeric Pain Rating Scale (NPRS), ASIA Impairment Scale (AIS), and Neuromuscular Recovery Scale (NRS). Functional MRI included resting-state and 4 tasks: imagining feeling the left leg, imagining moving the left leg, whole-body movement imagery, and a sensation task.
ResultsAfter CMR, participants improved on AIS with large effect sizes (touch: d=1.54; pinprick: d=1.83; lower limb motor function: d=1.32), while adaptive fitness had small/moderate effects (touch: d=0.49; pinprick: d=0.53; lower limb motor function: d=0.74). CMR also showed larger effect sizes for NRS (core: d=2.19; upper limb: d=0.69; lower limb: d=0.74) than fitness (core: d=0.73; upper limb: d=0.34; lower limb: d=0.00). Benefits persisted at follow-up. Highest neuropathic pain intensity reduced post-CMR and at 3-month follow-up (d=0.48; d=0.63). Pain increased slightly after fitness (n=6; d=-0.19; d=-0.41). CMR increased brain connectivity and activation during the leg imagery task. Increased activation during whole-body imagery was greater after CMR than fitness.
DiscussionThese preliminary results support the potential of CMR to improve function and reduce neuropathic pain in adults with SCI, warranting larger confirmatory trials.
Clinicaltrial.gov: NCT05167032