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.

Not Applicable

Completed

• Conditions: Chronic Paraplegia
• Interventions: Other: strengthening; Other: hybrid training programme

• Registration Number: NCT02042508
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Study Start: 2016-02-02
• Primary Completion: 2016-02-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paraplegic patients	hybrid training programme	-
Paraplegic patients	strengthening	-

Primary Outcome Measures

Name	Time	Method
Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test	Change from baseline in VO2max at 9 months

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France