Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency

Spinal Cord Injury Clinical Trial

— FRM  

Official title:

Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935687
• Other study ID #: P101006
• Status: Completed
• Phase: N/A
• First received: March 4, 2013
• Last updated: November 17, 2017
• Start date: December 2012
• Est. completion date: July 2015

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Using of instrumented wheel
Using of instrumented wheel
• Using of ergometer roller
Using of ergometer roller

Locations

Country	Name	City	State
France	Djamel Bensmail	Garches	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiological parameters using instrumented wheel	Heart rate, VO2 and Borg score.	6 min
Other	Physiological parameters using ergometer roller	Heart rate, VO2 and Borg score.	15 min
Primary	Mechanical power calculated by instrumented wheel and ergometer roller.	Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.	20 min
Secondary	Efficient fraction of total power calculated using instrumented wheel	Tangential power / total power	6 min
Secondary	Efficient fraction of total power calculated using ergometer roller	Tangential power / total power	15 min