Cervical spinal cord injury (SCI) leads to permanent impairment of arm and hand functions. Here we conducted a prospective, single-arm, multicenter, open-label, non-significant risk trial that evaluated the safety and efficacy of ARCEX Therapy to improve arm and hand functions in people with chronic SCI. ARCEX Therapy involves the delivery of externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation. The primary endpoints were safety and efficacy as measured by whether the majority of participants exhibited significant improvement in both strength and functional performance in response to ARCEX Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of participants demonstrated improvements greater than the minimally important difference criteria for both strength and functional domains. Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities and self-reported increases in quality of life. These results demonstrate the safety and efficacy of ARCEX Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier: NCT04697472.
Background and Purpose— The long-term effects of 6-weeks whole-body vibration, as a novel method of somatosensory stimulation, on postural control and activities of daily living were compared with those of 6 weeks of exercise therapy on music of the same intensity in the postacute phase of stroke. Methods— Fifty-three patients with moderate to severe functional disabilities were randomized within 6 weeks poststroke and within 3 days after admission to a rehabilitation center to either whole-body vibration or exercise therapy on music in addition to a regular inpatient rehabilitation program. The whole-body vibration group received 4×45-second stimulation on the Galileo 900 (30-Hz frontal plane oscillations of 3-mm amplitude) for 5 days per week during 6 weeks. The exercise therapy on music group received the same amount of exercise therapy on music. Outcome variables included the Berg Balance Scale, Trunk Control Test, Rivermead Mobility Index, Barthel Index, Functional Ambulation Categories, Motricity Index, and somatosensory threshold at 0, 6, and 12 weeks follow up. Results— At baseline, both groups were comparable in terms of prognostic factors and outcome measures. Both at 6 and 12 weeks follow up, no clinically relevant or statistical differences in outcome were observed between the groups. No side effects were reported. Conclusions— Daily sessions of whole-body vibration during 6 weeks are not more effective in terms of recovery of balance and activities of daily living than the same amount of exercise therapy on music in the postacute phase of stroke.
Van Nes IJW, Geurts ACH, Hendricks HT, Duysens J: Short-term effects of whole-body vibration on postural control in unilateral chronic stroke patients: Preliminary evidence. Am J Phys Med Rehabil 2004;83:867–873. The short-term effects of whole-body vibration as a novel method of somatosensory stimulation on postural control were investigated in 23 chronic stroke patients. While standing on a commercial platform, patients received 30-Hz oscillations at 3 mm of amplitude in the frontal plane. Balance was assessed four times at 45-min intervals with a dual-plate force platform, while quietly standing with the eyes opened and closed and while performing a voluntary weight-shifting task with visual feedback of center-of-pressure movements. Between the second and third assessments, four repetitions of 45-sec whole-body vibrations were given. The results indicated a stable baseline performance from the first to the second assessment for all tasks. After the whole-body vibration, the third assessment demonstrated a reduction in the root mean square (RMS) center-of-pressure velocity in the anteroposterior direction when standing with the eyes closed (P < 0.01), which persisted during the fourth assessment. Furthermore, patients showed an increase in their weight-shifting speed at the third balance assessment (P < 0.05) while their precision remained constant. No adverse effects of whole-body vibration were observed. It is concluded that whole-body vibration may be a promising candidate to improve proprioceptive control of posture in stroke patients.