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

NCT04566809 | Completed

• 1 other identifier: 3879A
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury at C5-C7 Level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Spinal Cord Independence Measure (SCIM)

  2 years

• Grasping Strength (GS)

  2 years

Study Arms (2)

Experimental group: FES+CBA

EXPERIMENTAL

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

Control Group: FES

ACTIVE COMPARATOR

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

Interventions

FES+CBA OTHER

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

Also known as: Functional Electric Stimulation, Cognitive Therapy

Experimental group: FES+CBA

FES OTHER

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

Also known as: Functional Electric Stimulation

Control Group: FES

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 28, 2020
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 21, 2017
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP