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Motor Conditioning to Enhance the Effect of Physical Therapy

NCT04367623 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-12-09

No results posted yet for this study

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

Interventions

OTHER

Brain computer interface based therapy

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

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Aleksandra Vuckovic, PhD · University of Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04367623 on ClinicalTrials.gov