Health TrialsbyHealthPanel

Investigating the Upper Limb During the First 6 Months After Sustaining a Cervical Spinal Cord Injury,

ConditionsSpinal Cord Injuries (SCI)Upper Limb Function
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

The goal of this observational study is to investigate and describe the injury patterns, secondary complications, and biomechanical properties of the upper limb during the initial 6 months post-SCI.

The overarching objective is to investigate and describe the trajectory of upper limb functioning, secondary complications, and biomechanical properties of the upper limb during the initial 6 months post-SCI and explore factors influencing functional use of the hands at 6 months after injury.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent

Acute onset Cervical SCI (traumatic and non-traumatic) C0-C7 AIS A-D that affects motor function in the upper limb.

Over the age of 18 at admission

Admitted for rehabilitation at one of the study sites.

Disqualifiers

For the surveys: Inability to understand Swedish or English in writing.

Trial population

All individuals with acute onset cervical SCI (traumatic and non-traumatic) C0-C7 AIS A-D that affects motor function in the upper limb at the following study sites will be invited; In Sweden; Region Skåne, Region Västerbotten, Region Stockholm, Västra Götalandsregionen. In New Zealand, the two national spinal units in Auckland and Christchurch. In Canada: Lyndhurst Toronto rehab, KITE, Toronto.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Assessment of upper limb function

    Other intervention

    Observational study of the changes in upper limb after SCI paralysis

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Motor neuron testing

Motor neuron testing, using the well established NeuroMuscular Electrical Stimulation (NMES). Identification of the LMN integrity in defined muscle will be done by surface electrical stimulation of the forearm according to standardized technique (Bersch 2018). A standard four-channel nerve stimulator ( Chattanooga Rehab SKU 2533110-INT) will be used and with stimulation parameters according to international recommendations for nerve/muscle stimulation; 20-80 mA, 250-300 μs at 35 Hz (Bersch 2022). All stimulators have CE approval, approved as medical technical product (medicinteknisk produkt) in Sweden and manuals in both Swedish and English are available. The stimulator will be used within approved area.

Time frame
1,2,3,6 months post injury

Secondary outcomes

Other outcomes

1

International Standards for Neurological Classification of SCI (ISNCSCI) including the American Spinal Injury Association Impairment Scale (AIS)

ISNCSCI and AIS are well-established international communication tools for researchers and clinicians to quantify the neurological impairment resulting from a spinal cord injury. (Kirshblum 2011) The ISNCSCI examine the motor- and sensory level of injury, C1- C7. While the AIS describe the completeness of the injury using a 5-point ordinal scale, classifying individuals from A" (complete SCI) to "E" (normal sensory and motor function) The ISNCSCI and AIS is part of clinical routine at admission and discharge

Time frame
At admission and discharge from inpatient setting. Both assessments will be from date of inclusion until the date of final assessment at 6 months (-1+2 months) or date withdrawn from study, whichever came first, assessed up to 8 months
2

Muscle strength

Active motor strength, as measured by the Medical Research Council are considered golden standard for muscle testing.

Time frame
1,2,3,6months
3

Modified Ashworth scale

Modified Ashworth scale (Baunsgaard 2016) is considered one of the golden standard measures in measuring spasticity in SCI. The scale go from 0-5 where 0=no spasticity and 5=rigid.

Time frame
1,2,3,6 months
4

Biomechanical balance of the hand

Observation of the maximal hand opening and closing.

Time frame
1,2,3,6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Promobilia Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: