Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Chronic Paraplegia

Treatments: Other: hybrid training programme; Other: strengthening

Study type: Interventional

Funder types: Other

Identifiers

NCT02042508

CASILLAS PARI 2011

Details and patient eligibility

About

This single-centre study was carried out in collaboration with the Cardiovascular Research Laboratory of Harvard University (Boston, USA). This preliminary study does not include a control group.

The aim of this study was to investigate the effect of a hybrid reconditioning programme (electrostimulation of the lower limb muscles associated with voluntary strengthening of the upper limbs) on a specially developed rowing machine in patients presenting stabilized paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic capacity (VO2max) between the start and end of the 9-month reconditioning programme.

Enrollment: 6 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients with paraplegia, ageb between 18 and 45 years
• Body mass index (BMI) between 18.5 and 29.9
• 2 to 15 years after the accident, ASIA A or B, lesion situated between T3 and T12
• Medically stable
• Able to follow instructions
• Persons who have provided written informed consent

Exclusion criteria

• Persons without national health insurance cover
• Arterial blood pressure > 140/90 mmHg, arrythmia, heart disease, diabetes, impaired kidney function, cancer
• smoking-induced intoxication,
• Medical treatment for cardiovascular disease or antidepressants
• Orthostatic hypotension with a symptomatic fall in arterial pressure > 30 mmHg in the vertical position
• Grade 2 or more pressure sores
• Other associated neurological diseases (e.g. cerebrovascular accident, peripheral neuropathy, myopathy)
• Any disease affecting the shoulder that may compromise the ability to use the rowing machine.
• Coagulation disorders;
• Presence of an implanted electronic device
• Epilepsy

Trial design

6 participants in 1 patient group

Paraplegic patients

Experimental group

Treatment:

Other: hybrid training programme

Other: strengthening