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

NCT06740279 | Not Yet Recruiting

• 3 other identifiers: InUL6SCIALFGBG-984319282763
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Cord Injuries (SCI); Upper Limb Function

Keywords

Spinal cord injury; Upper limb; tetraplegia; Quadriplegia; hand function; Activities of daily living; grip ability

Outcome Measures

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.

  1,2,3,6 months post injury

Other Outcomes (8)

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

  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 Both assessments will be from date of inclusion until the date of final assessment at 6 months (-1+2 months) or date withdrawn from study, whichever came first, assessed up to 8 months

• Muscle strength

  1,2,3,6months

• Modified Ashworth scale

  1,2,3,6 months

Interventions

Assessment of upper limb function OTHER

Observational study of the changes in upper limb after SCI paralysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Promobilia Foundation: collaborator

Related Publications (8)

• Harvey LA, Dunlop SA, Churilov L, Hsueh YS, Galea MP. Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial. Trials. 2011 Jan 17;12:14. doi: 10.1186/1745-6215-12-14.

  PMID: 21235821 RESULT

• Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.

  PMID: 15672628 RESULT

• Grampurohit N, Bell A, Duff SV, Mulcahey MJ, Thielen CC, Kaplan G, Marino RJ. Highlighting gaps in spinal cord injury research in activity-based interventions for the upper extremity: A scoping review. NeuroRehabilitation. 2021;49(1):23-38. doi: 10.3233/NRE-210042.

  PMID: 33967071 RESULT

• Snoek GJ, IJzerman MJ, Hermens HJ, Maxwell D, Biering-Sorensen F. Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics. Spinal Cord. 2004 Sep;42(9):526-32. doi: 10.1038/sj.sc.3101638.

  PMID: 15224087 RESULT

• Baunsgaard CB, Nissen UV, Christensen KB, Biering-Sorensen F. Modified Ashworth scale and spasm frequency score in spinal cord injury: reliability and correlation. Spinal Cord. 2016 Sep;54(9):702-8. doi: 10.1038/sc.2015.230. Epub 2016 Feb 9.

  PMID: 26857270 RESULT

• Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.

  PMID: 22330108 RESULT

• Bersch I, Koch-Borner S, Friden J. Electrical stimulation-a mapping system for hand dysfunction in tetraplegia. Spinal Cord. 2018 May;56(5):516-522. doi: 10.1038/s41393-017-0042-2. Epub 2018 Jan 22.

  PMID: 29358674 RESULT

• Bersch I, Krebs J, Friden J. A Prediction Model for Various Treatment Pathways of Upper Extremity in Tetraplegia. Front Rehabil Sci. 2022 Jun 30;3:889577. doi: 10.3389/fresc.2022.889577. eCollection 2022.

  PMID: 36188973 RESULT

Related Links

• Swedish research database. English title:Investigating the upper limb during the first 6 months after sustaining a cervical spinal cord injury

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johanna Wangdell, PhD

  Västra Götalandsregionen, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Wangdell, PhD

CONTACT

+46702992112; johanna.wangdell@gu.se

Jennifer A Dunn, PhD

CONTACT

+64211364079; jennifer.dunn@otago.ac.nz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share