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

Primary Purpose

Spinal Cord Injury at C5-C7 Level

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FES+CBA
FES
Sponsored by
Azienda Ospedaliero, Universitaria Pisana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Spinal Cord Injury at C5-C7 Level

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group: FES+CBA

    Control Group: FES

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Performance test: Bimanual Ability Test (BAT)
    10 items evaluated, each one from 0 to 60 seconds. Less time needed means better skills

    Secondary Outcome Measures

    Spinal Cord Independence Measure (SCIM)
    The score varies from 0 to 100. Higher the score, patient more independent in its daily life
    Grasping Strength (GS)
    Grasping Strength evaluated with a dynamometer (from 1 to 90 kg) more kg means more strength

    Full Information

    First Posted
    September 14, 2020
    Last Updated
    September 22, 2020
    Sponsor
    Azienda Ospedaliero, Universitaria Pisana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04566809
    Brief Title
    Cognitive Rehabilitation and FES for Hand Functionality in Persons With Cervical Spinal Cord Injury
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2017 (Actual)
    Study Completion Date
    October 21, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliero, Universitaria Pisana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury at C5-C7 Level

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group: FES+CBA
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group: FES
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    FES+CBA
    Other Intervention Name(s)
    Functional Electric Stimulation, Cognitive Therapy
    Intervention Description
    The experimental treatment was formerly composed by 20 sessions of FES for the hand in combination with a structured cognitive therapy
    Intervention Type
    Other
    Intervention Name(s)
    FES
    Other Intervention Name(s)
    Functional Electric Stimulation
    Intervention Description
    The control treatment was formerly composed by 20 sessions of FES for the hand
    Primary Outcome Measure Information:
    Title
    Performance test: Bimanual Ability Test (BAT)
    Description
    10 items evaluated, each one from 0 to 60 seconds. Less time needed means better skills
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Spinal Cord Independence Measure (SCIM)
    Description
    The score varies from 0 to 100. Higher the score, patient more independent in its daily life
    Time Frame
    2 years
    Title
    Grasping Strength (GS)
    Description
    Grasping Strength evaluated with a dynamometer (from 1 to 90 kg) more kg means more strength
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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