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.
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedStudy Start
First participant enrolled
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2016
CompletedMay 3, 2019
May 1, 2019
Same day
January 17, 2014
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test
Change from baseline in VO2max at 9 months
Study Arms (1)
Paraplegic patients
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female patients with paraplegia, ageb between 18 and 45 years
- Body mass index (BMI) between 18.5 and 29.9
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Dijon
Dijon, 21079, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2014
First Posted
January 23, 2014
Study Start
February 2, 2016
Primary Completion
February 2, 2016
Last Updated
May 3, 2019
Record last verified: 2019-05