G82.23
Conditions
Interventions
Group 1: Intervention: neuromuscular feedback therapy with the HAL® exoskeleton over 12 weeks with 5 appointments per week of 60 minutes each.
Group 2: Control intervention: therapies for spinal cord
Sponsors
Gemeinsamer Bundesausschuss (G-BA)
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. chronic, incomplete cervical, thoracic or lumbar paraplegia or complete paraplegia with preserved residual voluntary motor function in the lower extremities 2. more than 1 year after the onset of paraplegia 3. treatment at the expense of the GKV 4. height = 150 and = 190 cm, body weight = 40 and = 100 kg 5. age = 18 and = 75 years 6. no further improvement in walking ability to be expected with conventional therapy in line with the guidelines
Exclusion criteria
Exclusion criteria: 1. contractures 2. massive spinal spasms 3. cardiac devices or other electronic implants that are impaired by the use of the exoskeleton 4. pre-existing conditions that lead to an increased risk for patients, such as 5. high-grade osteoporosis or condition after spontaneous fractures, not fully consolidated fractures 6. coronary heart disease, pulmonary embolism in the past 7. neurological diseases such as Parkinson's disease, epilepsy, severe dementia 8. acute psychiatric illnesses (e.g. depression, bipolar disorder, anxiety disorder, etc.), alcohol or drug addiction 9. decubital ulceration 10. more than 5 training sessions with the HAL exoskeleton in the past 11. pregnancy and breastfeeding 12. lack of language comprehension or lack of capacity to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response in terms of improvement in walking ability 3 months after randomisation (end-of-treatment), defined as achieving at least one of the following three criteria: Improvement (1) in WISCI-II score by = 2 points, (2) in speed in the 6-minute walk test (6MWT) by = 0.1 m/s, (3) in speed in the 10-metre walk test (10MWT) by = 0.15 m/s | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment response 6 and 9 months after randomisation, 6MWT, 10MWT, WISCI-II score, health-related quality of life (WHOQOL-Bref); (neuropathic) pain (NRS and SCIPI); bladder function (SF-Qualiveen); bowel function (NBD score) each 3, 6 and 9 months after randomisation | — |
Countries
Germany
Outcome results
None listed