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Completed

NCT Number: NCT04303728

Use of Muscle Ultrasound to Predict Function

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

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, 569766

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle Ultrasound

Diagnostic Test

The muscle thickness and muscle quality will be assessed on ultrasound

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Official study title

Muscle Ultrasound as a Predictor of Functional Status in Spinal Cord Injury Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2020
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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