CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Neuroprosthesis-FES Therapy +1 moredevice
Likely dose
Compex Motion neuroprosthesis multi-channel surface stimulation system for palmar and lateral graspAI-extracted
Key inclusion· 2
  • Traumatic spinal cord lesion, incomplete, between C4 and C7
  • Enrolled within first six months post-SCI
Key exclusion· 5
  • Uncontrolled hypertension
  • Susceptibility to autonomic dysreflexia
  • Pressure ulcer present
  • Cardiac pacemakers

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00221117
NCT00221117N/ACompleted

Neuroprosthesis for Improving Grasping Function in Spinal Cord Injured Patients

Toronto Rehabilitation Institute·interventional·Posted Sep 22, 2005·Updated Jul 24, 2018

In Brief

A clinical study evaluating Neuroprosthesis-FES Therapy and Conventional Ocupational Therapy (COT) for Spinal Cord Injuries. Completed, enrolled 22 participants.

Detailed Summary

Functional electrical stimulation is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing.The study is designed to evaluate the effectiveness and long term benefits of applying functional electrical simulation during early rehabilitation to improve grasping function in persons who have suffered a spinal cord injury. By using functional electrical stimulation,these patients could potentially improve their grasping function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartAug 1, 2005
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 20.8 years ago

Interventions

Neuroprosthesis-FES Therapydevice

The Compex Motion neuroprostesis, developed by Drs. R. Popovic and Thierry Keller,and company Compex SA, ia a flexible device designed to improve grasping function in both SCI and stroke patients.This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp , and holds a number of advantages over the other existing neuroprostheses.

Conventional Ocupational Therapy (COT)other

Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach; b) task-specific, repetitive functional training; c) strengthening and motor control training using resistance to available arm motion to increase strength; d) stretching exercises; e) electrical stimulation applied primarily for muscle strengthening (this is not FES but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.