Motor Conditioning to Enhance the Effect of Physical Therapy

NCT04367623 | Terminated

• 1 other identifier: GN19NE396
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal Cord Injury (SCI) affects person's ability to move and feel sensation from the body. About half of patients with tetraplegia (high level SCI) have an incomplete injury, i.e. have some sensation and control of muscles preserved and could recover some function of their upper limbs. In this study the researchers would like to increase the effect of physical therapy of the upper limbs by sensory-motor priming. To achieve this they will use Brain Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) immediately prior to the physical therapy of the upper limbs. BCI will be operated by motor attempt (motor priming) which will activate the FES applied to participants' hand muscles to achieve movement (sensory and motor priming). Physical therapy in this study will not replace conventional therapy that participant receive as a part of their standard treatment. There will be two groups: a treatment group (BCI FES with physical therapy) and a control group (physical therapy only), each receiving 20 therapy sessions of matched duration (40-50 min) of their dominant hand. Based on power analysis and results from our study (Osuagwu et al. 2016, J Neural Eng) there will be thirteen participants per group matched by age and the level of injury. Therapy will be applied to dominant hand only, because of the limited time available for experimental studies on participants who are already under active rehabilitation programme. Primary measures will be functional outcomes (range of movement, muscle strength, grip force, independence) while secondary outcomes will be neurological outcomes (EEG activity) and quality of life measures. The outcomes will be compared between the treatment and the control group and between the dominant and the non-dominant hand of each participant.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

• Changes in Spinal Cord Independence measure (range 0 to 100, max 100)

  Spinal Cord Independence measure Questionnaire regarding independence in activities of daily living

  two months: baseline and upon completion of the therapy, typically 9 weeks

• Change in the hand range of motion (range 0 to 90 degress, max 90 degress)

  Change in the range of motion measured by goniometer (o degrees)

  two months: baseline and upon completion of thetherapy, typically 9 weeks

• Changes in the Manual muscle test (range 0 to 5, max 5)

  Change of strength of individual hand and arm muscles

  two months: baseline and upon completion of the therapy, typically 9 weeks

• Change in grip strength (range 0 to 80 N, max 80 N)

  Change in grip strength (N)

  two months: baseline and upon completion of the therapy, typically 9 weeks

Secondary Outcomes (5)

• Changes in Multichannel brain activity measured by electroencephalography (EEG) during attempted or imagined movements

  two months: baseline and after completion of the therapy, typically 9 weeks

• Changes in baseline multichannel electroencephalogaphy (EEG) measurement

  two months: baseline and upon completion of the therapy, typically 9 weeks

• Changes NASA (National Aeronautics and Space Administration) task load index

  after 1st, 10st and 20th therapy session (typically 0, 3 and 9 weeks -there is a washout peiord between first and last 10 sesions)

• Quebec User Evaluation of Satisfaction with Assistive Technology

  Upon completion of the therapy, typically 9 weeks

• Patient feedback, satisfaction with therapy

  Upon completion of the therapy, typically 9 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients receiving conventional hand therapy, time matched to the duration of total intervention in the Active group

Other: Brain computer interface based therapy

Active

ACTIVE COMPARATOR

Patients receiving BCI FES prior to the conventional therapy

Other: Brain computer interface based therapy

Interventions

Brain computer interface based therapy OTHER

Participants who decide to take part will be assigned to a treatment or a control group. Both groups will have the same assessments and the same number of therapy sessions. Therapy group will have a training that consists of Brain Computer Interface controlled Functional Electrical Stimulation followed by a physical practice of the dominant upper limb, while the control group will have a physical practice only. One experimental session will last about 60 min for both groups (including setup and therapy) and participants in each group will receive 20 sessions, about 3 times per week. The expected time needed for completion of 20 sessions is 7 weeks

Active; Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Upper and lower age limit as above
• Incomplete spinal cord injury at level C3-C8 or complete spinal cord injury (C3-C8) with a zone of partially preserved innervation
• Sub-acute patients, likely to remain as inpatient during the period of study
• Normal or corrected to normal vision

You may not qualify if:

• Self reported neurological conditions prior to the injury that are expected to substantially change the EEG signal (e.g. stroke, epilepsy, brain injury, Parkinson's disease)
• Inability to understand the experimental task
• Brain, brachioplexus or peripheral nerve damage occurring at the time of the spinal cord injury.
• General contraindications for using FES (implanted devices, pregnancy, sensitive skin, automatic dysreflexia)
• Halos (large neck supports surrounding head) preventing EEG recording
• Inability to sit for 1.5 hour due to skin redness or sores
• Infections and general poor health due to injury
• Unable to speak English

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

University of Glasgow

Glasgow, G12 8QQ, United Kingdom

Location

Related Publications (1)

• Osuagwu BC, Wallace L, Fraser M, Vuckovic A. Rehabilitation of hand in subacute tetraplegic patients based on brain computer interface and functional electrical stimulation: a randomised pilot study. J Neural Eng. 2016 Dec;13(6):065002. doi: 10.1088/1741-2560/13/6/065002. Epub 2016 Oct 14.

  PMID: 27739405 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Aleksandra Vuckovic, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: April 29, 2020
• Study Start: December 9, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)