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OpenTrials
Completed

NCT Number: NCT02042508

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.

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.

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Key information

Conditions

Chronic Paraplegia

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Dijon

Dijon, 21079, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strengthening

Other

hybrid training programme

Other

Primary outcomes

  1. Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test

    Time frame: Change from baseline in VO2max at 9 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
First posted
Jan 23, 2014
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.