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ATTEND-Family-led Rehabilitation After Stroke in India (ATTEND)

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ClinicalTrials.gov Identifier: NCT02123875
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : April 28, 2014
Sponsor:
Collaborator:
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
jeyarajpandian, Christian Medical College and Hospital, Ludhiana, India

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Other: Physiotherapy Other: Control arm Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-led Rehabilitation After Stroke in India
Study Start Date : December 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Control arm
Routine hospital based physiotherapy
Other: Control arm
Routine hospital based physiotherapy
Physiotherapy intervention arm
Caregiver delivered, home based physiotherapy
Other: Physiotherapy



Primary Outcome Measures :
  1. Change in modified Rankin Score [ Time Frame: 3rd and 6th month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123875


Locations
India
Christian Medical College and Hospital
Ludhiana, Punjab, India, 141008
Sponsors and Collaborators
Christian Medical College and Hospital, Ludhiana, India
The George Institute for Global Health, Australia
Investigators
Principal Investigator: Jeyaraj D Pandian, MD DM FRACP Christian Medical College and Hospital

Responsible Party: jeyarajpandian, Professor and Head, Department of Neurology, Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier: NCT02123875     History of Changes
Other Study ID Numbers: 0001
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases