Use of Muscle Ultrasound to Predict Function

NCT ID: NCT04303728

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Muscle ultrasound

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

Group Type EXPERIMENTAL

Muscle ultrasound

Intervention Type DIAGNOSTIC_TEST

The muscle thickness and muscle quality will be assessed on ultrasound

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Muscle ultrasound

The muscle thickness and muscle quality will be assessed on ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew Tay, MD

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DSRB 2019/00923

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.