Condition category
Nervous System Diseases
Date applied
08/04/2009
Date assigned
12/05/2009
Last edited
23/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mary Reilly

ORCID ID

Contact details

MRC Centre for Neuromuscular Diseases
National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
+44 (0)20 7837 3611 ext. 3457
m.reilly@ion.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12

Study information

Scientific title

Strengthening hip muscles to improve walking distance in people with Charcot-Marie-Tooth disease: a randomised single-blinded crossover trial

Acronym

Study hypothesis

To ascertain whether training the hip flexor muscles allows them to increase in strength. The study then aims to explore whether these strength changes allow the hip flexor muscles to be utilised for longer when walking and thus improve walking endurance.

Ethics approval

Barnet, Enfield and Haringey Local Research Ethics Committee, 27/02/2009, ref: 09/H0723/6

Study design

Randomised single-blinded crossover trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Charcot-Marie-Tooth disease

Intervention

There will be two 16-week periods with an 8-week washout phase post-exercise intervention. Subjects will be assigned to two groups and will either continue their normal activities or will target the hip flexors muscles. Measures of strength and functional ability will be recorded at the start and finish of each 16-week period. Thirty two subjects will be randomly allocated to the two groups. A blinded assessor will record the outcome measures.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Isometric muscle strength of the hip flexors - measured using fixed myometry.

Timepoints:
Group A: Baseline (0 weeks), post-intervention (16 weeks), post-washout (24 weeks), final measurement (40 weeks)
Group B: Baseline (0 weeks), post-control (16 weeks), post-intervention (32 weeks), post-washout (40 weeks)

Secondary outcome measures

1. Six Minute Timed Walk Test: change in maximal walking distance in 6 minutes and peak heart rate
2. Walking speed: using a Timed 10 Metre Walk Test
3. Perceived exertion during the Six Minute Timed Walk Test: using the Borg 15-point scale
4. Heart rate and Physiological Cost Index (PCI) during the Six Minute Timed Walk Test: using a heart rate monitor
5. Fatigue: assessed using the Fatigue Severity Scale (FSS)
6. Perception of walking ability: Walk-12 scale
7. Disease severity: Charcot-Marie-Tooth Symptom/Sign Score (CMTSS)
8. Physical limitations: Overall Neuropathy Limitations Scale (ONLS)
9. Pain: assessed using the Visual Analogue Scale (VAS)

Timepoints:
Group A: Baseline (0 weeks), post-intervention (16 weeks), post-washout (24 weeks), final measurement (40 weeks)
Group B: Baseline (0 weeks), post-control (16 weeks), post-intervention (32 weeks), post- washout (40 weeks)

Overall trial start date

01/04/2009

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

People will be recruited provided all of the following criteria are satisfied:
1. Clinical diagnosis of Charcot-Marie-Tooth disease (CMT)
2. Aged 18 to 70 years, either sex
3. Able to walk for 50 m with or without a walking aid or orthotic devices
4. Signed informed participant consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

People will be excluded from the study if one or more of the following criteria apply:
1. Presence of other significant neurological disorders (such as multiple sclerosis, cerebrovascular diseases, movement disorders), or major comorbidities (e.g., definite cognitive impairment, psychiatric disease, heart or lung failure, orthopaedic or rheumatological disorders)
2. Limb surgery during the six months prior to screening (or planned before final assessment)
3. Severe congenital hip dysplasia associated with CMT
4. Aged over 70 or under 18 years
5. Women of child-bearing age only if they are pregnant at the inclusion into the study or plan to become pregnant during the study (people agreeing not to become pregnant during the study must take appropriate contraceptive methods - contraceptive pill, intrauterine device, barrier methods)

Recruitment start date

01/04/2009

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Hospital for Neurology and Neurosurgery
London
WC1N 3BG
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

Joint UCLH & UCL Biomedical Research Unit (R&D)
Rosenheim Wing
Ground Floor
25 Grafton Way
London
WC1E 5DB
United Kingdom
-
philip.diamond@uclh.nhs.uk

Sponsor type

Government

Website

http://www.uclh.nhs.uk/

Funders

Funder type

Charity

Funder name

Muscular Dystrophy Campaign (MDC) (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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25582960

Publication citations

Additional files

Editorial Notes

23/05/2016: Publication reference added.