ATTEND-Family-led Rehabilitation After Stroke in India

This study has been completed.
Sponsor:
Collaborator:
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
jeyarajpandian, Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier:
NCT02123875
First received: April 11, 2014
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention
Stroke
Other: Physiotherapy
Other: Control arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-led Rehabilitation After Stroke in India

Resource links provided by NLM:


Further study details as provided by Christian Medical College and Hospital, Ludhiana, India:

Primary Outcome Measures:
  • Change in modified Rankin Score [ Time Frame: 3rd and 6th month ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control arm
Routine hospital based physiotherapy
Other: Control arm
Routine hospital based physiotherapy
Physiotherapy intervention arm
Caregiver delivered, home based physiotherapy
Other: Physiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 11, 2014
Last Updated: April 24, 2014
Health Authority: India: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014