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NCT02123875 Clinical Trial

ATTEND-Family-led Rehabilitation After Stroke in India

Stroke Clinical Trial

— ATTEND  

Official title:
Family-led Rehabilitation After Stroke in India

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02123875
Other study ID # 0001
Secondary ID
Status Completed
Phase N/A
First received April 11, 2014
Last updated April 24, 2014
Start date December 2011
Est. completion date March 2013

Study information
Verified date April 2014
Source Christian Medical College and Hospital, Ludhiana, India
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

ATTEND Trial is based on early supported discharge- home based stroke rehabilitation model which proves to offer several advantages in low and mid income countries. The objectives of the pilot stude were to determine that with a randomized blinded outcome assessor, controlled trial, family- led caregiver- delivered home based rehabilitation is better than usual care for those with disabling stroke in India and the feasibility of this model.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults (>18 years)

- Recent (<1 month) acute ischaemic/haemorrhagic/ undifferentiated stroke

- Residual disability (requiring help from another person for everyday activities)

- Expected to survive to discharge from hospital with a reasonable expectation of six month survival

- Able (or by proxy) to provide informed consent

Exclusion Criteria:

- Unable to identify a suitable family - nominated caregiver for training and subsequent delivery of care

- Those unwilling/unable to adhere to follow up.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Physiotherapy

• Control arm
Routine hospital based physiotherapy

Locations
Country Name City State
India Christian Medical College and Hospital Ludhiana Punjab

Sponsors (2)
Lead Sponsor Collaborator
Christian Medical College and Hospital, Ludhiana, India The George Institute for Global Health, Australia

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in modified Rankin Score 3rd and 6th month No
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