Generalised versus targeted physiotherapy in childhood hypermobility
| ISRCTN | ISRCTN58523390 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58523390 |
| Secondary identifying numbers | 04/Q1502/7 |
- Submission date
- 11/08/2009
- Registration date
- 02/10/2009
- Last edited
- 04/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Beresford
Scientific
Scientific
Department of Rheumatology
Royal Liverpool Children's NHS Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
Study information
| Study design | Randomised comparative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised comparative trial of generalised versus targeted physiotherapy in the management of childhood hypermobility |
| Study acronym | The Hypermobility Trial |
| Study objectives | This study aimed to compare a generalised exercise programme with a targeted programme within a randomised trial and assess the impact of these interventions on symptom scores. |
| Ethics approval(s) | Liverpool Childrens Local Research Ethics Committee approved on the 26th April 2004 (ref: 04/Q1502/7) |
| Health condition(s) or problem(s) studied | Symptomatic hypermobility |
| Intervention | Each child received six, sequential, weekly appointments for individual half-an-hour physiotherapy treatments, in which the allocated intervention was administered. Patients were randomised to a General Exercise Program or Targeted Exercise Program. |
| Intervention type | Other |
| Primary outcome measure | Improvement in the child's pain assessment score. Younger children used a faces scale ranging from 1 to 5 while older children (age greater than 11 years) used a Visual Analogue Scale (VAS). Participants were asked to indicate on the linear 100 mm scale their pain level in the past week. Change in pain-VAS was used to assess the impact of therapy on symptoms. Measured at baseline (pre-treatment), midpoint (following 6-week intervention) and follow up (3 months after midpoint). |
| Secondary outcome measures | 1. Parent's assessment of their child's pain: parental-VAS 2. Parent's global evaluation of the impact of their child's hypermobility in the previous week: global-VAS 3. Functional impairment measured using the Childhood Health Assessment Questionnaire (CHAQ) 4. Six-minute shuttle test (measured at baseline and midpoint only) Measured at baseline (pre-treatment), midpoint (following 6 week intervention) and follow up (3 months after midpoint). |
| Overall study start date | 01/06/2004 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 108 |
| Key inclusion criteria | 1. Children aged 7 to 16 years, either sex 2. Treated at the Department of Rheumatology, Royal Liverpool Children's NHS Trust, Liverpool, UK between June 2004 and May 2007 3. Identified as having symptomatic hypermobility* 4. Symptomatic patients had arthralgia for three preceding months or more *Children were hypermobile if they met Revised Criteria for benign joint hypermobility syndrome (BJHS). In brief, they had to fulfil either two major criteria, one major and two minor criteria, four minor criteria, or two minor criteria and a first degree relative with hypermobility. Major criteria were: 1. Beighton score of greater than 4 2. Arthralgia in greater than 4 joints Minor criteria included: 1. Beighton score less than 4 2. Arthralgia in less than 4 joints 3. Mechanical back pain for greater than 3 months 4. Hypermobility in first degree relative Beighton score assesses hypermobility of the following: placing hands flat on floor without bending knees, hyperextension of knees and elbows greater than 100, little finger metacarpalphalangeal hyperextension to greater than 900, bending thumb to forearm. |
| Key exclusion criteria | Patients were excluded if they refused consent. |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Rheumatology
Liverpool
L12 2AP
United Kingdom
L12 2AP
United Kingdom
Sponsor information
Royal Liverpool Children's NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Ms Dot Lambert
Research and Development Manager
Research and Development Department
Eaton Road
Liverpool
L12 2AP
England
United Kingdom
| Website | http://www.alderhey.com |
|---|---|
"ROR" |
https://ror.org/00p18zw56 |
Funders
Funder type
Government
Royal Liverpool Children's NHS Trust (UK) - Research and Development Department
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2010 | Yes | No |
