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Coma arousal program for severe head injury patients

Safety, Feasibility and Efficacy of Subject Specific Integrated Multi-Sensory Stimulation Program For Patients with Severe Traumatic Brain Injury in Acute setup

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031440
Enrollment
30
Registered
2021-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: G939- Disorder of brain, unspecified

Interventions

Intervention1: Subject specific integrated multi sensory stimulation program (SSIMS): Subject Specific Integrated Multi-Sensory Stimulation Program (SSIMS) is a newly structured stimulation program co

Sponsors

Aarsi Shah
Lead Sponsor
Gokul hospital
Collaborator
Sanganis Multispeciality Hospital
Collaborator
School Of physiotherapy RK University
Collaborator
Wockhardt Hospitals
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: -Glasgow Coma Scale (GCS) =8 for =24h from the event -Stable hemodynamic (absence of dangerous variations of Mean Arterial Pressure or Heart Rate -Admitted to the neurosurgical unit -Approval of treating physician

Exclusion criteria

Exclusion criteria: -History of prior brain injury -Premorbid history of uncorrected visual or hearing impairments -Premorbid history of developmental, psychiatric, or neurologic illness resulting in documented functional disability up to the time of the injury -Coma or persistent vegetative state not caused by TBI -Acute medical illness -Medical complications during the study -Active Otorrhoea or Rhinorrhoea

Design outcomes

Primary

MeasureTime frame
Coma recovery scale- revisedTimepoint: Baseline, everyday till day 14

Secondary

MeasureTime frame
Agitated behavioral scaleTimepoint: baseline, everyday till day 14;Disorders of consciousness scale DOCS-25Timepoint: Baseline,everyday till day 14;GCSTimepoint: Baseline, everyday till day 14;Glasgows outcome scale extended (GOS-E)Timepoint: On discharge/on 14th day;Length of stay (in days)Timepoint: At discharge;Rancho los amigos scale RLATimepoint: baseline,everyday till day 14;The Full Outline of UnResponsiveness (FOUR) score scaleTimepoint: baseline,everyday till 14th day

Countries

India

Contacts

Public ContactDr Priyanshu Rathod

School of Physiotherapy ,R K University

aarsishah007@gmail.com9265719216

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026