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Use of Muscle Ultrasound to Predict Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04303728
Recruitment Status : Completed
First Posted : March 11, 2020
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Tan Tock Seng Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Diagnostic Test: Muscle ultrasound Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Muscle Ultrasound as a Predictor of Functional Status in Spinal Cord Injury Patients
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : January 30, 2022
Actual Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Muscle ultrasound
Muscle ultrasound will be performed for the patient on admission and at 1-2 months from inpatient rehabilitation.
 Diagnostic Test: Muscle ultrasound
The muscle thickness and muscle quality will be assessed on ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. Functional Independence Score [ Time Frame: Baseline (Performed on admission to inpatient rehabilitation) ]
    An 18-item of physical, psychological and social function (graded from 1-7)

  2. Functional Independence Score [ Time Frame: Performed at 1-2 months after starting rehabilitation ]
    An 18-item of physical, psychological and social function (graded from 1-7)

  3. Functional Independence Score [ Time Frame: Performed at 3-6 months ]
    An 18-item of physical, psychological and social function (graded from 1-7)

  4. Functional Independence Score [ Time Frame: Performed at 1 year ]
    An 18-item of physical, psychological and social function (graded from 1-7)

  5. Spinal Cord Independence Measure (SCIM) III [ Time Frame: Baseline (Performed on admission to inpatient rehabilitation) ]
    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.

  6. Spinal Cord Independence Measure (SCIM) III [ Time Frame: Performed at 1-2 months after starting rehabilitation ]
    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.

  7. Spinal Cord Independence Measure (SCIM) III [ Time Frame: Performed at 3-6 months ]
    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.

  8. Spinal Cord Independence Measure (SCIM) III [ Time Frame: Performed at 1 year ]
    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.

  9. ASIA score [ Time Frame: Baseline (Performed on admission to inpatient rehabilitation) ]
    This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

  10. ASIA score [ Time Frame: Performed at 1-2 months after starting rehabilitation ]
    This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

  11. ASIA score [ Time Frame: Performed at 3-6 months ]
    This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

  12. ASIA score [ Time Frame: Performed at 1 year ]
    This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

  13. Walking Index for Spinal Cord Injury II (WISCI II) [ Time Frame: Baseline (Performed on admission to inpatient rehabilitation) ]
    A walking scale used by health care practitioners to grade the walking ability of SCI patients.

  14. Walking Index for Spinal Cord Injury II (WISCI II) [ Time Frame: Performed at 1-2 months after starting rehabilitation ]
    A walking scale used by health care practitioners to grade the walking ability of SCI patients.

  15. Walking Index for Spinal Cord Injury II (WISCI II) [ Time Frame: Performed on 3-6 months ]
    A walking scale used by health care practitioners to grade the walking ability of SCI patients.

  16. Walking Index for Spinal Cord Injury II (WISCI II) [ Time Frame: Performed on 1 year ]
    A walking scale used by health care practitioners to grade the walking ability of SCI patients.


Secondary Outcome Measures :
  1. Range of motion of elbow, hip and knee [ Time Frame: Baseline (Performed on admission to inpatient rehabilitation) ]
    Range of motion of elbow, hip and knee

  2. Range of motion of elbow, hip and knee [ Time Frame: Performed at 1-2 months after starting rehabilitation ]
    Range of motion of elbow, hip and knee

  3. Range of motion of elbow, hip and knee [ Time Frame: Performed at 3-6 months ]
    Range of motion of elbow, hip and knee

  4. Range of motion of elbow, hip and knee [ Time Frame: Performed at 1 year ]
    Range of motion of elbow, hip and knee

  5. Spasticity [ Time Frame: Baseline (Performed on admission to inpatient rehabilitation) ]
    (2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity

  6. Spasticity [ Time Frame: Performed at 1-2 months after starting rehabilitation ]
    (2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity

  7. Spasticity [ Time Frame: Performed at 3-6 months ]
    (2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity

  8. Spasticity [ Time Frame: Performed at 1 year ]
    (2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303728


Locations
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Singapore
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, Singapore, 569766
Sponsors and Collaborators
Tan Tock Seng Hospital
Investigators
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Principal Investigator: Matthew Tay, MD Tan Tock Seng Hospital
More Information
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Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT04303728    
Other Study ID Numbers: DSRB 2019/00923
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries