Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MS41
Study information
Scientific title
Acronym
Study hypothesis
After suffering a stroke most patients have problems using the affected arm and hand, but achieve varying degrees of recovery over the ensuing months. Most patients receive routine physiotherapy.
The aim of this study was to investigate the use of more intensive physiotherapy to see if this improved arm and hand function.
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
Stroke rehabilitation
Intervention
Participants were allocated to one of three treatment groups
1. Routine physiotherapy (RPT)
2. Qualified physiotherapist (QPT)
3. Assistant physiotherapist (APT)
The patients in the last group were assessed initially by a qualified physiotherapist who then supervised the treatment of each patient by the assistant weekly. Routine physiotherapy involved about 2-3 hours a week for all disabilities, while patients in the other two groups received 2 hours of additional treatment for their arm each week for 5 weeks (ten hours in total).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The principal measures used at five weeks:
1. Rivermead Motor Assessment Arm Scale
2. Action Research Arm Test.
Secondary outcome measures
Other tests measured
1. dexterity
2. grip
3. motor function
4. self- care
5. other daily living abilities
The later assessments comprised four of these tests.
Outcomes were assessed after five weeks, three months, and six months.
Overall trial start date
01/10/1994
Overall trial end date
01/04/1998
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with admitted to Nottingham City Hospital following a stroke were entered in the study between one and five weeks later, after giving consent. All patients had normal arm function prior to the stroke, and were assessed as able to accept the physiotherapy programme.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
282 (Added 19/11/09)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/10/1994
Recruitment end date
01/04/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Psychology
Nottingham
NG7 2RP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
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
Results - basic reporting
Publication summary
1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10066854
2. 1999 results on analysis of arm impairment severity in http://www.ncbi.nlm.nih.gov/pubmed/10392645
Publication citations
-
Results
Lincoln NB, Parry RH, Vass CD, Randomized, controlled trial to evaluate increased intensity of physiotherapy treatment of arm function after stroke., Stroke, 1999, 30, 3, 573-579.
-
Results on analysis of arm impairment severity
Parry RH, Lincoln NB, Vass CD, Effect of severity of arm impairment on response to additional physiotherapy early after stroke., Clin Rehabil, 1999, 13, 3, 187-198.