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Completed

NCT Number: NCT04566809

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FES+CBA

Other

The experimental treatment was formerly composed by 20 sessions of FES for the hand in combination with a structured cognitive therapy

Other names: Functional Electric Stimulation, Cognitive Therapy

FES

Other

The control treatment was formerly composed by 20 sessions of FES for the hand

Other names: Functional Electric Stimulation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

Cognitive Approach Using Functional Electric Stimulation for Grasp and Pinch Rehabilitation in Persons Affected by Cervical Spinal Cord Injury, a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2020
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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