NCT04303728

Brief Summary

Establish if change from the baseline in ultrasound muscle parameters over 2 months of rehabilitation correlates with functional status of SCI patients at the end of rehabilitation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

January 29, 2020

Last Update Submit

April 26, 2022

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (16)

  • Functional Independence Score

    An 18-item of physical, psychological and social function (graded from 1-7)

    Baseline (Performed on admission to inpatient rehabilitation)

  • Functional Independence Score

    An 18-item of physical, psychological and social function (graded from 1-7)

    Performed at 1-2 months after starting rehabilitation

  • Functional Independence Score

    An 18-item of physical, psychological and social function (graded from 1-7)

    Performed at 3-6 months

  • Functional Independence Score

    An 18-item of physical, psychological and social function (graded from 1-7)

    Performed at 1 year

  • Spinal Cord Independence Measure (SCIM) III

    It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.

    Baseline (Performed on admission to inpatient rehabilitation)

  • Spinal Cord Independence Measure (SCIM) III

    It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.

    Performed at 1-2 months after starting rehabilitation

  • Spinal Cord Independence Measure (SCIM) III

    It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.

    Performed at 3-6 months

  • Spinal Cord Independence Measure (SCIM) III

    It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.

    Performed at 1 year

  • ASIA score

    This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

    Baseline (Performed on admission to inpatient rehabilitation)

  • ASIA score

    This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

    Performed at 1-2 months after starting rehabilitation

  • ASIA score

    This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

    Performed at 3-6 months

  • ASIA score

    This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

    Performed at 1 year

  • Walking Index for Spinal Cord Injury II (WISCI II)

    A walking scale used by health care practitioners to grade the walking ability of SCI patients.

    Baseline (Performed on admission to inpatient rehabilitation)

  • Walking Index for Spinal Cord Injury II (WISCI II)

    A walking scale used by health care practitioners to grade the walking ability of SCI patients.

    Performed at 1-2 months after starting rehabilitation

  • Walking Index for Spinal Cord Injury II (WISCI II)

    A walking scale used by health care practitioners to grade the walking ability of SCI patients.

    Performed on 3-6 months

  • Walking Index for Spinal Cord Injury II (WISCI II)

    A walking scale used by health care practitioners to grade the walking ability of SCI patients.

    Performed on 1 year

Secondary Outcomes (8)

  • Range of motion of elbow, hip and knee

    Baseline (Performed on admission to inpatient rehabilitation)

  • Range of motion of elbow, hip and knee

    Performed at 1-2 months after starting rehabilitation

  • Range of motion of elbow, hip and knee

    Performed at 3-6 months

  • Range of motion of elbow, hip and knee

    Performed at 1 year

  • Spasticity

    Baseline (Performed on admission to inpatient rehabilitation)

  • +3 more secondary outcomes

Study Arms (1)

Muscle ultrasound

EXPERIMENTAL

Muscle ultrasound will be performed for the patient on admission and at 1-2 months from inpatient rehabilitation.

Diagnostic Test: Muscle ultrasound

Interventions

Muscle ultrasoundDIAGNOSTIC_TEST

The muscle thickness and muscle quality will be assessed on ultrasound

Muscle ultrasound

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First ever acute SCI
  • Age 21-65 years
  • Presence of weakness in the lower limbs (defined as either ASIA A, B, C or D)
  • Independent in ambulation prior to onset of SCI
  • Able to understand study procedures and sign informed consent
  • Clinical suitability for rehabilitation

You may not qualify if:

  • Presence of premorbid lower musculoskeletal conditions eg contractures, fractures, previous operations, that prevents proper ultrasound assessment of the affected limb
  • Cardiorespiratory conditions eg congestive cardiac failure (EF\<40%), chronic arrhythmias, COPD stage 3-4
  • End stage illness, end stage renal failure, life expectancy \<6 months
  • Other active neurological conditions
  • Botulinum toxin injection over the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, 569766, Singapore

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Matthew Tay, MD

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 29, 2020

First Posted

March 11, 2020

Study Start

February 1, 2020

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)