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A study to find which hand splint better improves grip strength and daily hand use in people with cervical spinal cord injury

Effectiveness of Lateral Grasp Prehension Orthosis versus Tenodesis Splint in Improving Grip Strength and hand function in Individuals with C6 C7 Cervical Spinal Cord Injury: A Randomized Controlled Superiority Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100891
Enrollment
49
Registered
2026-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S141- Other and unspecified injuries ofcervical spinal cord

Interventions

Intervention1: Lateral Grasp Prehension Orthosis (LGPO): This study is an interventional, randomized controlled superiority trial with a two-arm, parallel-group design comparing the effectiveness of t

Sponsors

All India Institute of Medical Sciences Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 to 50 years diagnosed with cervical spinal cord injury at neurological level C6 or C7, with ASIA Impairment Scale grade A B C or D, and duration of injury at least three months with medical stability. Participants must be able to understand study procedures, provide informed consent, and follow instructions. Skin over the wrist and hand must be intact and suitable for orthotic wear. Individuals must be willing to comply with the intervention schedule and attend all follow up assessments.

Exclusion criteria

Exclusion criteria: Severe upper-limb contractures or uncontrolled spasticity Painful shoulder/hand pathology limiting participation Active pressure ulcers or dermatitis at orthosis contact sites Use of upper-limb neuroprosthetics or new assistive technology during study Other neurological conditions affecting hand function

Design outcomes

Primary

MeasureTime frame
Functional hand performance: Grip/pinch strength (hand dynamometer; lateral/key pinch gauge). Functional independence: FIM self-care sub score. Timepoint: Baseline (T0), Mid-treatment Week 3 (T1), End-treatment Week 6 (T2), Follow-up Week 10 (T3).

Secondary

MeasureTime frame
Patient-reported outcomes: COPM (performance/satisfaction) Adherence: Wear time and home program logs. Safety: Incidence of device-related skin issues/pain. Timepoint: Baseline (T0), Mid-treatment Week 3 (T1), End-treatment Week 6 (T2), Follow-up Week 10 (T3).

Countries

India

Contacts

Public ContactSanyal Kumar

All India Institute of Medical Sciences Patna

kumar.sanyal@gmail.com9721760824

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026