Study design: Series of four single subjects with and without intervention design.
Objectives: To describe a minimally invasive surgical technique used to implant the Freehand System during initial spinal cord injury (SCI) rehabilitation and to report rehabilitation outcomes of four recently injured adolescents using the Freehand System.
Setting: Nonprofit children's hospital specializing in orthopedic and SCI care.
Methods: Four subjects with C5 tetraplegia between 13 and 16 years of age and between 9 and 16 weeks following traumatic SCI underwent implantation of the Freehand System using minimally invasive surgical techniques. Outcomes on muscle strength, pinch force, hand function, performance of activities of daily living and satisfaction with and without the Freehand System were collected.
Results: Each subject was successfully implanted with the Freehand System without perioperative complications and employed the Freehand System during therapy services and ad lib on the rehabilitation floor. At the last follow-up, every subject remained a motor candidate for the Freehand System. With the Freehand System, average lateral and palmar pinch force was 1.8 and 1.6 kg respectively; average pinch force without functional electrical stimulation (FES) was 0.29 kg. With the Freehand System, three subjects improved their rate of performance on The Upper Extremity Capabilities Questionnaire. All subjects increased their level of independence on The Quadriplegia Index of Function. On the Canadian Occupational Performance Measure (COPM) with the Freehand System, average performance and satisfaction scores improved for every patient. Three of the four subjects continued to use the system at home.
Conclusion: This case series demonstrates that the Freehand System can vastly improve hand function and performance of rehabilitation activities within days after a minimally invasive implant procedure during initial SCI rehabilitation. Satisfaction with the Freehand System beyond initial rehabilitation is evidenced by continued use at home.