Clinical trial NCT01935687: Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency
Official title: Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Instrumented Wheel
Manual Wheelchair
Spinal Cord Injury (SCI)
Manual wheelchair Users
Aged between 18-70 years
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to validate an instrumented wheel such as a new biomedical device. The physicians will compare this instrumented wheel with another instrumentation "Ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured.

The increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.

Detailed description: \* The manual wheelchair is used by people for whom walking is difficult or impossible due to spinal cord lesions, neurological and muscular diseases, lower limb trauma, age ...etc.

Although the wheelchair help to regain mobility, this made of displacement is nor natural nor well-to-do.

* The CIC-IT and TSR (Transmissions Services Roulements, Mérignac, France) improved the instrumented wheel, adaptable with all wheelchairs, with information wireless transmission.
* The primary objective of study is to validate the instrumented wheel of manual wheelchair such as a new device of evaluation of capacities of displacement in ecologic situation.
* The primary criteria is to compare the mechanical power calculated using instrumented wheel versus the power calculated using ergometer roller during protocol of standard cardio-respiratory stress test.

This study is interventional, mono-centric, controlled and crossover. The population concerned is patients with spinal cord injury (SCI) and users of manual wheelchair.

Number of subjects projected for the entire study: 62 patients The total duration of participation of each patient: 7 days ±2days

Eligibility criteria: Inclusion Criteria:

* Age : 18-70 years.
* Spinal cord injured patient.
* User of manual wheelchair for daily locomotion (having at least 30/100 at displacement items of WST questionnaire) .
* Affiliation to a social security scheme or entitled.
* Informed consent dated and signed by subject or subject's legally acceptable representative (and investigator).

Exclusion Criteria:

* Cognitive troubles.
* Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.

Primary outcomes:
measure: Mechanical power calculated by instrumented wheel and ergometer roller.
timeFrame: 20 min
Secondary outcomes:
measure: Efficient fraction of total power calculated using instrumented wheel
timeFrame: 6 min
measure: Efficient fraction of total power calculated using ergometer roller
timeFrame: 15 min
Other outcomes:
measure: Physiological parameters using instrumented wheel
timeFrame: 6 min
measure: Physiological parameters using ergometer roller
timeFrame: 15 min
Locations:
city: Garches
country: France
facility: Djamel Bensmail
state: Hauts-de-Seine
Study officials:
affiliation: Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
name: Djamel Bensmail, MD
role: PRINCIPAL_INVESTIGATOR
References: