Reciprocating gait orthosis powered with electrical muscle stimulation (RGO II). Part I: Performance evaluation of 70 paraplegic patients.

Seventy paraplegics were fitted with an improved Reciprocating Gait Orthosis powered with or without (low-level injury) electrical stimulation of the thigh muscles (RGO II) as a secondary rehabilitation phase after the acute period. The patients comprised a broad cross-section of the paraplegic population applying for medical services and varied in age from 16 to 55 years, time since injury ranging from less than 1 to 15 years, injury levels ranging from C-6/7 to T-11/12, and varying levels of spasticity, contractures, scoliosis and other related medical and physiologic problems. The success/failure ratio was dependent on the injury level, which was 1:1 for paraplegics with injury level at C-6/7; 1.67:1 for those with injury of T-1/3; and about 4:1 for paraplegics with injury level from T-3 to T-12. Lack of motivation and medical problems unrelated to the RGO II treatment were the primary reasons for failure. The duration of treatment (outpatient service three times per week) ranged from 2 to 48 weeks (mean: 16). Forty-one patients who completed the RGO II rehabilitation and were sent home with the orthosis for independent use (for at least 6 months and up to 3 years) were surveyed by a staff member for analysis of the meaning and impact of the RGO II on the patient's life and health, and potential problems. It was shown that 80.5% of the 41 patients were regular users and 19.5% were non-users. Thirty-eight of the 41 patients declined an offer to return the RGO II equipment for a full refund, while three patients were willing to return the orthosis. It was concluded that the RGO II is viable orthosis for restoring standing and limited walking in paraplegics while providing sufficient function, safety, and reliability. The most appropriate patients for the use of such an orthosis consist primarily of those with T-3 to T-12 injury level and good motivation, although highly selected patients with higher injury levels also can benefit from its use. Regular use of the RGO II, even for exercise only, had a general positive impact on the patients' health and outlook.