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.

May 2, 2019 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paraplegic patients
Other: strengthening
Other: hybrid training programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test
Time Frame: Change from baseline in VO2max at 9 months
Change from baseline in VO2max at 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2016

Primary Completion (Actual)

February 2, 2016

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASILLAS PARI 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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