Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
531019
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Traumatic brain injury
Intervention
Head injured patients were randomised into the conventional group and the intensive group:
1. Subjects belonging to the conventional group underwent the usual programme of physiotherapy, occupational therapy and speech therapy 2 hours a day, 5.5 days a week
2. For those in the intensive group, therapy time was doubled to 4 hours per day without changing the content of the therapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
01/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Moderate (Glasgow Coma Score [GCS] 9 - 12) and severe (GCS 8/15) traumatic brain injury
2. Aged from 12 to 65 years old
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/2002
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Division of Neurosurgery
-
-
Hong Kong
Sponsor information
Organisation
Hong Kong Health Services Research Fund (Hong Kong)
Sponsor details
Health Welfare and Food Bureau
Government Secretariat
HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
+852 (0)2973 8288
hsrf@hwfb.gov.hk
Sponsor type
Government
Website
http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html
Funders
Funder type
Government
Funder name
Hong Kong Health Services Research Fund (Hong Kong)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17653942
Publication citations
-
Results
Zhu XL, Poon WS, Chan CC, Chan SS, Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial., Brain Inj, 2007, 21, 7, 681-690, doi: 10.1080/02699050701468941.