Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Rehabilitation and FES for Hand Functionality in Persons With Cervical Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04566809
Recruitment Status : Completed
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Matteo Olivieri, Azienda Ospedaliero, Universitaria Pisana

Brief Summary:
16 persons affected by Cervical-SCI were recruited for the study and randomly assigned to the Control Group (CG) or to the Experimental Group (EG). Persons of the CG (n = 8) executed 20 sessions of FES for the rehabilitation of hand functions (grasp or pinch), participants of the EG (n = 8) performed 20 sessions of FES and CBA in addition. The primary assessment was a modified version of Bimanual Activity Test (10 tasks); also, SCIM-II and measurement of grasping strength only in participants submitted to grasp rehabilitation were evaluated.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury at C5-C7 Level Other: FES+CBA Other: FES Not Applicable

Detailed Description:

Each participant followed twenty sessions of hand rehabilitation, three times per week. Each treatment, for both CG and EG, lasted about forty minutes.

The FES devices chosen for this research stimulated "grasp" or "pinch" function: the NESS H200 (NESS Ltd., Ra'anana, Israel) was used if patient needed to improve the grasp functions, otherwise the Microstim (Microstim, Medel, Hamburg, Germany) was used to increase pinch functions. In order to provide FES, the five electrodes of NESS H200 were first humidified with warm water and then inserted in the right size place of the rigid splint worn by the patient, while Microstim was used with four standard electrodes, two for each muscle treated. In both case the stimulation was triggered by the therapist clicking a button (Table 1).

The participants of CG received only FES to improve their manipulating skills without the interaction with objects, but only with the muscle contraction induced by the devices.

The participants of EG executed FES and CBA treatment which means that during the stimulation they manipulated different tools. In particular, for the first ten sessions the participants were invited to manipulate specific objects: squares, rectangles and pyramids of different sizes; touch on plastic test tubes coated with materials of different consistency; these two exercises were performed both with open and closed eyes. Finally, for the last ten sessions the participants were asked to execute specific tasks, depending on person's life before the lesion.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cognitive Approach Using Functional Electric Stimulation for Grasp and Pinch Rehabilitation in Persons Affected by Cervical Spinal Cord Injury, a Randomized Controlled Trial
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group: FES+CBA
FES+CBA participants executed FES and CBA treatment which means that during the stimulation they manipulated different tools. In particular, for the first ten sessions the participants were invited to manipulate specific objects: squares, rectangles and pyramids of different sizes; touch on plastic test tubes coated with materials of different consistency; these two exercises were performed both with open and closed eyes. Finally, for the last ten sessions the participants were asked to execute specific tasks, depending on person's life before the lesion.
Other: FES+CBA
The experimental treatment was formerly composed by 20 sessions of FES for the hand in combination with a structured cognitive therapy
Other Name: Functional Electric Stimulation, Cognitive Therapy

Active Comparator: Control Group: FES
FES participants received only FES to improve their manipulating skills without the interaction with objects, but only with the muscle contraction induced by the devices.
Other: FES
The control treatment was formerly composed by 20 sessions of FES for the hand
Other Name: Functional Electric Stimulation




Primary Outcome Measures :
  1. Performance test: Bimanual Ability Test (BAT) [ Time Frame: 2 years ]
    10 items evaluated, each one from 0 to 60 seconds. Less time needed means better skills


Secondary Outcome Measures :
  1. Spinal Cord Independence Measure (SCIM) [ Time Frame: 2 years ]
    The score varies from 0 to 100. Higher the score, patient more independent in its daily life

  2. Grasping Strength (GS) [ Time Frame: 2 years ]
    Grasping Strength evaluated with a dynamometer (from 1 to 90 kg) more kg means more strength



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • C-SCI with neurological level between C2-T1;
  • reduced ability of hand functions;
  • excitable muscles and FES tolerability.

Exclusion Criteria:

  • any trauma or surgery to the target hand or upper limb within the last 12 months,
  • amputation of any digits on the target hand,
  • severe spasticity in the target hand or upper limb preventing use of the instruments,
  • experienced autonomic dysreflexia or hypotension in response to FES,
  • any contraindication to FES such as: cardiac pacemaker, epilepsy, forearm fracture, pregnancy, skin lesions, cancer or tumor, intracranial metal implants
Layout table for additonal information
Responsible Party: Matteo Olivieri, Principal Investigator, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT04566809    
Other Study ID Numbers: 3879A
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Statistical Analysis Plan (SAP)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System