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

Spinal Cord Injury at C5-C7 Level Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566809
• Other study ID #: 3879A
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: October 21, 2017

Study information

• Verified date: September 2020
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 21, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury at C5-C7 Level
• Wounds and Injuries

Intervention

Other:
• FES+CBA
The experimental treatment was formerly composed by 20 sessions of FES for the hand in combination with a structured cognitive therapy
• FES
The control treatment was formerly composed by 20 sessions of FES for the hand

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance test: Bimanual Ability Test (BAT)	10 items evaluated, each one from 0 to 60 seconds. Less time needed means better skills	2 years
Secondary	Spinal Cord Independence Measure (SCIM)	The score varies from 0 to 100. Higher the score, patient more independent in its daily life	2 years
Secondary	Grasping Strength (GS)	Grasping Strength evaluated with a dynamometer (from 1 to 90 kg) more kg means more strength	2 years