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Comparing effects of exercise with rest on healing of sacral segment (of spine) pressure ulcer in individuals with spinal cord injury

Not Applicable
Conditions
Health Condition 1: S141- Other and unspecified injuries ofcervical spinal cord
Registration Number
CTRI/2019/08/020870
Lead Sponsor
Indian Spinal Injuries Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Subjects who have sustained complete or incomplete Spinal Cord Injury (SCI) more than 3 months prior to recruitment;

Site of Pressure Ulcer: Sacral Segment;

Diagnosed grade I and II pressure ulcer;

Traumatic and Non-traumatic SCI;

Level of injury: All levels of SCI

Exclusion Criteria

Primary causes other than SCI leading to PU such as diabetes mellitus, malnutrition, active smoking, chronic obstructive pulmonary disease, immuno-suppression, vascular disease, poor mental health, mobility problems other than SCI and poorly fitted medical devices in direct contact with patient tissues;

Subjects with Pressure ulcer in anatomical sites other than sacrum;

Subjects with multiple PUs

Subjects having cognitive or verbal impairments;

Subjects with any diagnosed autoimmune disease;

Subjects with moderate to severe Anemia (less than 7.0 g/dl-9 g/dl);

Subjects with protein deficiency with serum Albumin levels less than 35g/L;

Subjects using NSAIDS;

Subjects undergoing Chemotherapy;

Subjects with alcohol abuse

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pressure Ulcer Scale for Healing (PUSH) Score V.3.0Timepoint: 0 6 and 12 week
Secondary Outcome Measures
NameTimeMethod
Pressure ulcer risk factors will be assessed using the Braden Scale for Predicting Pressure Sore Risk <br/ ><br>b.Health-related quality of life will be assessed using World Health Organization Quality of Life Assessment Instrument-Bref (WHOQOL-Bref) <br/ ><br>Hospital Anxiety and Depression Scale (HADS) <br/ ><br>ComplicationsTimepoint: 0 6 and 12 week
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