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Use of Muscle Ultrasound to Predict Function

T

Tan Tock Seng Hospital

Status

Completed

Conditions

Spinal Cord Injury

Treatments

Diagnostic Test: Muscle ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT04303728
DSRB 2019/00923

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

21+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Muscle ultrasound
Experimental group
Description:
Muscle ultrasound will be performed for the patient on admission and at 1-2 months from inpatient rehabilitation.
Treatment:
Diagnostic Test: Muscle ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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