FES Arm Cycling on Functional Ability and Strength in People With SCI

NCT07385456 | Completed

• 1 other identifier: 347696
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this feasibility study is to determine if Functional Electrical Stimulation (FES) arm cycling can be used to improve arm functional ability and arm strength in people with Spinal Cord Injury (SCI). The main questions it aims to answer are:

• What is the feasibility of FES UL cycling in people with acute tetraplegia?
• What are the potential effects of FES UL cycling on strength and functional ability in people with acute tetraplegia? Participants will:
• Complete an FES arm cycling intervention 3 times a week for 6 weeks.
• Complete assessments for upper limb function and strength pre and post-intervention.
• Complete questionnaires about upper limb and overall function and quality of life, pre and post-intervention.

Conditions

Spinal Cord Injuries (SCI); Upper Limb Function

Keywords

Spinal cord injury (SCI); FES Arm cycling; Functional Electrical Stimulation (FES); Upper limb functional ability; Upper limb strength

Outcome Measures

Primary Outcomes (1)

• Recruitment

  Recruitment rate (%)

  From enrollment to the end of the intervention at week 7

Secondary Outcomes (9)

• Attrition

  From enrolment to the end of treatment at 7 weeks

• Adherence

  From enrolment to the end of treatment at 7 weeks

• Adverse Events

  From enrolment to the end of treatment at 7 weeks

• Perceived burden

  From enrolment to the end of treatment at 7 weeks

• Muscle Strength

  From enrolment to the end of treatment at 7 weeks

Study Arms (1)

FES Arm Cycling

EXPERIMENTAL

FES arm cycling applied for up to 30 minutes. The intervention will be conducted 3 times a week for 6 weeks.

Other: Functional electrical stimulation (FES) arm cycling

Interventions

Functional electrical stimulation (FES) arm cycling OTHER

FES arm cycling 3 times a week for 6 weeks.

FES Arm Cycling

Eligibility Criteria

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

You may qualify if:

• Inpatient at QENSIU
• Cervical level SCI (C8 or above) both complete and incomplete of less than 1 year in duration
• Medically stable to engage in physical rehabilitation
• Able to maintain seated position in manual or electric wheelchair for 3-4 hours per day
• Upper Extremity Motor Score below 30/50 on the ISNCSCI

You may not qualify if:

• Under 18 years old
• Unable to understand English (written and spoken)
• Uncontrolled Autonomic Dysreflexia
• Uncontrolled epilepsy
• Pregnant
• Current cancer diagnosis
• Pacemaker in situ
• Any upper limb injuries that may prevent participation in upper limb cycling e.g. arm fracture or open wound
• Taking part in another rehabilitation SCI trial that involves training of the upper limb

Sponsors & Collaborators

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

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

proto-oncogene protein c-fes-fps

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Cohort, Feasibility design

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: February 4, 2026
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

GB (1)