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.

Chronic Paraplegia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042508
• Other study ID #: CASILLAS PARI 2011
• Status: Completed
• Phase: N/A
• Start date: February 2, 2016

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. primary completion date: February 2, 2016
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Paraplegia
• Paraplegia

Intervention

Other:
• strengthening

• hybrid training programme

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test		Change from baseline in VO2max at 9 months