NCT02123875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

April 11, 2014

Last Update Submit

April 24, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in modified Rankin Score

    3rd and 6th month

Study Arms (2)

Control arm

OTHER

Routine hospital based physiotherapy

Other: Control arm

Physiotherapy intervention arm

OTHER

Caregiver delivered, home based physiotherapy

Other: Physiotherapy

Interventions

Physiotherapy intervention arm

Routine hospital based physiotherapy

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to identify a suitable family - nominated caregiver for training and subsequent delivery of care
  • Those unwilling/unable to adhere to follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

Location

Related Publications (2)

  • Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

  • Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Jeyaraj D Pandian, MD DM FRACP

    Christian Medical College and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head, Department of Neurology

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 28, 2014

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 28, 2014

Record last verified: 2014-04

Locations