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Use of Muscle Ultrasound to Predict Function

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Muscle ultrasound
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Cord Injury

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Tan Tock Seng Hospital Rehabilitation Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Muscle ultrasound

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Range of motion of elbow, hip and knee
Range of motion of elbow, hip and knee
Range of motion of elbow, hip and knee
Range of motion of elbow, hip and knee
Range of motion of elbow, hip and knee
Range of motion of elbow, hip and knee
Range of motion of elbow, hip and knee
Range of motion of elbow, hip and knee
Spasticity
(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity
Spasticity
(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity
Spasticity
(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity
Spasticity
(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity

Full Information

First Posted
January 29, 2020
Last Updated
April 26, 2022
Sponsor
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04303728
Brief Title
Use of Muscle Ultrasound to Predict Function
Official Title
Muscle Ultrasound as a Predictor of Functional Status in Spinal Cord Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Rehabilitation is the key to ambulatory recovery in patients with spinal cord injury, although only 25% of patients regain this ability despite current rehabilitation protocols. There is emerging evidence that intensive and prolonged rehabilitation, though costly and manpower intensive, may result in ambulatory recovery in patients previously thought to be non-ambulant. However, there are no suitable clinical biomarkers which can identify these group of patients who will benefit from this intervention. Hence the aim is to establish if change from the baseline in ultrasound muscle parameters over rehabilitation correlates with functional status of SCI patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle ultrasound
Arm Type
Experimental
Arm Description
Muscle ultrasound will be performed for the patient on admission and at 1-2 months from inpatient rehabilitation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Muscle ultrasound
Intervention Description
The muscle thickness and muscle quality will be assessed on ultrasound
Primary Outcome Measure Information:
Title
Functional Independence Score
Description
An 18-item of physical, psychological and social function (graded from 1-7)
Time Frame
Baseline (Performed on admission to inpatient rehabilitation)
Title
Functional Independence Score
Description
An 18-item of physical, psychological and social function (graded from 1-7)
Time Frame
Performed at 1-2 months after starting rehabilitation
Title
Functional Independence Score
Description
An 18-item of physical, psychological and social function (graded from 1-7)
Time Frame
Performed at 3-6 months
Title
Functional Independence Score
Description
An 18-item of physical, psychological and social function (graded from 1-7)
Time Frame
Performed at 1 year
Title
Spinal Cord Independence Measure (SCIM) III
Description
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.
Time Frame
Baseline (Performed on admission to inpatient rehabilitation)
Title
Spinal Cord Independence Measure (SCIM) III
Description
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.
Time Frame
Performed at 1-2 months after starting rehabilitation
Title
Spinal Cord Independence Measure (SCIM) III
Description
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.
Time Frame
Performed at 3-6 months
Title
Spinal Cord Independence Measure (SCIM) III
Description
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.
Time Frame
Performed at 1 year
Title
ASIA score
Description
This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation
Time Frame
Baseline (Performed on admission to inpatient rehabilitation)
Title
ASIA score
Description
This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation
Time Frame
Performed at 1-2 months after starting rehabilitation
Title
ASIA score
Description
This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation
Time Frame
Performed at 3-6 months
Title
ASIA score
Description
This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation
Time Frame
Performed at 1 year
Title
Walking Index for Spinal Cord Injury II (WISCI II)
Description
A walking scale used by health care practitioners to grade the walking ability of SCI patients.
Time Frame
Baseline (Performed on admission to inpatient rehabilitation)
Title
Walking Index for Spinal Cord Injury II (WISCI II)
Description
A walking scale used by health care practitioners to grade the walking ability of SCI patients.
Time Frame
Performed at 1-2 months after starting rehabilitation
Title
Walking Index for Spinal Cord Injury II (WISCI II)
Description
A walking scale used by health care practitioners to grade the walking ability of SCI patients.
Time Frame
Performed on 3-6 months
Title
Walking Index for Spinal Cord Injury II (WISCI II)
Description
A walking scale used by health care practitioners to grade the walking ability of SCI patients.
Time Frame
Performed on 1 year
Secondary Outcome Measure Information:
Title
Range of motion of elbow, hip and knee
Description
Range of motion of elbow, hip and knee
Time Frame
Baseline (Performed on admission to inpatient rehabilitation)
Title
Range of motion of elbow, hip and knee
Description
Range of motion of elbow, hip and knee
Time Frame
Performed at 1-2 months after starting rehabilitation
Title
Range of motion of elbow, hip and knee
Description
Range of motion of elbow, hip and knee
Time Frame
Performed at 3-6 months
Title
Range of motion of elbow, hip and knee
Description
Range of motion of elbow, hip and knee
Time Frame
Performed at 1 year
Title
Spasticity
Description
(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity
Time Frame
Baseline (Performed on admission to inpatient rehabilitation)
Title
Spasticity
Description
(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity
Time Frame
Performed at 1-2 months after starting rehabilitation
Title
Spasticity
Description
(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity
Time Frame
Performed at 3-6 months
Title
Spasticity
Description
(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity
Time Frame
Performed at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Tay, MD
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital Rehabilitation Centre
City
Singapore
ZIP/Postal Code
569766
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Muscle Ultrasound to Predict Function

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