NCT06583538

Brief Summary

The goal of this feasibility study is to explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with Spinal Cord Injury during the transition from hospital to home. The main question\[s\] it aims to answer are:

  • What is the feasibility of an online rehabilitation programme to support physical activity adherence in people with spinal cord injury following discharge into the community?
  • How effective is an online rehabilitation programme to enhance functional capacity, physical activity and quality of life in people with spinal cord injury following discharge into the community? Participants will be given a personalised online rehabilitation programme to complete two times a week. It will consist of a warm up two exercise components (cardiorespiratory fitness and muscle strength) and a cool down.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

December 15, 2023

Last Update Submit

November 21, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Adherence

    Adherence will be monitored remotely by the number of online diary entries per participant.á Adherence will then be calculated based on percentage of completed sessions per week over the 12 weeks.Following the guidelines, the optimum number of completed sessions per participant is 2 x 20 mins cardiorespiratory and 2 strengthening per week. \>75% = excellent , 50-75% = good, \<50% = satisfactory, \<25% = low.

    12 weeks

  • Acceptability

    Acceptability will be captured by the structured online video interview. Thematic analysis will be used to assess the qualitative data.

    Week 6 to week 12

  • Participant recruitment and retention

    Measured by assessing participant eligibility (number of those approached and those who meet the inclusion criteria), recruitment rate per month and retention of recruited participants.

    12 weeks

Secondary Outcomes (7)

  • Self-report Physical Activity Scale for individuals with Physical Disabilities (PASIPD)

    Baseline, Week 2, Week 6 and week 12

  • 6-minute wheelchair test (6minWCT) OR 6-minute walk test (6MinWT)

    Baseline and week 6

  • Muscle Strength in kg

    Baseline and week 6

  • Borg Rate of Perceived Exertion (RPE) Scale

    Baseline and week 6

  • Walking Index for Spinal Cord Injury (WISCI II)

    Baseline and week 6

  • +2 more secondary outcomes

Study Arms (1)

Online Exercise

EXPERIMENTAL

Online personalised rehabilitation consisting of strengthening, aerobic and stretching. 40mins per session, twice per week, for 12 weeks

Other: Giraffe Healthcare

Interventions

An online personalised rehabilitation platform consisting of exercise videos with written and audio instruction, an exercise diary, advice and in-built messaging system between therapist and participant. The exercise prescription consists of strengthening, aerobic and stretching. 40mins per session, twice per week, for 12 weeks

Online Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient at the Queen Elizabeth National Spinal Injuries Unit
  • Incomplete or complete spinal cord injury of less than one year in duration
  • Medically stable to engage in physical rehabilitation and physical activity
  • Able to engage in manual wheelchair propulsion and / or weight baring activities
  • Discharge date anticipated within the next 4 weeks
  • Access and capability to use the internet

You may not qualify if:

  • Under 18 years old
  • Chronic spinal cord injury patients more than one year since injury
  • Discharge planned to another hospital or care facility
  • Co-morbidities which would preclude taking part in a physical activity programme: medically diagnosed ischemic heart disease; unstable angina, dysrhythmia or unstable autonomic dysreflexia; recent osteoporotic fracture, tracheostomy, current pressure injury, current substance dependence, psychosis, severe chronic upper extremity pain, surgery pending within 6 months, recurrent infection or illness requiring hospitalization (Bombardier et al., 2021).
  • Those who do not wish to take part in a physical activity research study
  • Unable to understand written and spoken English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, Scotland, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord InjuriesSedentary Behavior

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavior

Study Officials

  • Elaine Coulter, PhD

    Glasgow Caledonian University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2023

First Posted

September 4, 2024

Study Start

November 22, 2023

Primary Completion

October 8, 2024

Study Completion

October 8, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations