|
Welcome
|
|
02 September 2010
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke |
| ISRCTN | ISRCTN45392701 |
| ClinicalTrials.gov identifier | |
| Public title | Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke |
| Scientific title | Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: a pilot randomised controlled trial with observer blinding |
| Acronym | Ped-Ex |
| Serial number at source | N/A |
| Study hypothesis |
UNICAM-assisted upright pedalling (UNICAM-assisted UP), when used as an adjunct to conventional therapy, enhances recovery of lower limb motor function in people with substantial paresis 3 - 30 days after stroke. Is there sufficient evidence of benefit to justify proceeding to larger scale clinical trials?
The trial will also investigate which stroke survivors are most likely to benefit from UNICAM-assisted UP by linking pre-stated prognostic indicators to the ability to pedal or not. |
| Ethics approval |
1. Essex 1 Research Ethics Committee approved on the 27th August 2009 (ref: 09/H0301/52)
2. Research Governance Approval by East Norfolk and Waveney Research Governance Committee given on the 24th September 2009 (ref: 2009MFE04 [158-09-09]) |
| Study design | Single centre randomised controlled pilot trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke with substantial paresis of the lower limb |
| Participants - inclusion criteria |
1. Adults aged 18 years and over, either sex
2. Three to thirty days following a unilateral stroke resulting in unilateral muscle weakness with or without sensory deficit 3. Considered fit to participate by a consultant-led medical team fully engaged with the research process. Participants will have resting oxygen saturations of 95% and above, resting heart rate 90 beats per minute or less and systolic blood pressure of 100 - 160 mmHg. 4. Score of 0, 1 or 2 on the Functional Ambulation Categories. Clinically, this means unable to walk; or need the help of two or more people; or require firm continuous or intermittent support of one person assisting with weight and balance. 5. Able to sit unsupported for 30-seconds on the edge of a bed with feet on the floor 6. Able to follow a one-stage command i.e. sufficient communication, orientation and memory to participate in this cycling intervention 7. Sat out of bed in a chair or wheelchair at least once for a continual period of 15 minutes, i.e., have appropriate sitting tolerance to participate in this cycling intervention 8. Independently mobile with or without an aid prior to the index stroke |
| Participants - exclusion criteria |
One or more co-existing pathologies contributing to substantial impairment in either lower limb, e.g., osteoarthritis with severe deformity
|
| Anticipated start date | 01/11/2009 |
| Anticipated end date | 30/03/2011 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 24 (12 in each trial arm) |
| Interventions |
All participants will receive routine conventional physical therapy (CPT) as deemed appropriate by the clinical team. To describe and quantify the routine therapy and consequently improve the ability to replicate in research and clinical practice, a standardised schedule to record details of the conventional treatment will be used.
Control intervention: Participants allocated to the control group will receive CPT only as described above. Duration: Baseline and outcomes measures sessions only, times as intervention group Experimental intervention: Participants allocated to the experimental group will receive UNICAM-assisted UP in addition to CPT. All experimental participants will be asked to pedal at 50 revolutions per minute (50 rpm) at a comfortable resistance whilst maintaining a heart rate of 85% or below their age-predicted maximum (i.e., less than 220 - age x 0.85 beats per minute). If patients cannot achieve 50 rpm, the research therapist will be guided by their response in setting the maximum rpm. The mean rpm achieved will be recorded for each participant for each intervention session. It is anticipated that few patients this early after stroke will immediately manage ten minutes of pedalling, so the number of minutes pedalled, up to ten minutes, will be recorded. Duration: Baseline measures x 1 session = 30 minutes, daily pedalling for up to ten minutes for up to ten days = 100 minutes intervention maximum over ten days, outcome measures x 1 session = 30 minutes. Each intervention session will also involve recording: 1. The pedal crank setting 2. The degree of reciprocal activation of antagonistic muscle groups via EMG 3. The timing of onset and offset of activity in antagonistic muscle groups via EMG 4. The distance pedalled as recorded by the exercise cycle This description of each intervention session will allow replication of the intervention and information on how to progress the intervention over time in subsequent clinical trials. |
| Primary outcome measure(s) |
1. Measurement of clinical efficacy: ability to voluntarily contract paretic muscle as measured by the Motricity Index lower limb section. This is a widely used measure, with established validity and reliability for use after stroke. It is an ordinal score with six measurement levels within each of three categories for the lower limb. The three categories are: ankle dorsiflexion, knee extension, and hip flexion. For each movement, a score of 0, 9, 14, 19, 25, or 33 is given, where 0 is no movement, 19 is full range movement against gravity not against resistance and 33 is normal power.
2. Prognostic indicator measures: 2.1. Site of stroke lesion (determined from scan and liaison with medical team) 2.2. Degree of muscle weakness as measured by the Motricity Index (see clinical efficacy measures) 2.3. Ambulatory Capacity as measured by the Functional Ambulatory Categories: this scale is designed to give detail on physical support needed by patients for walking, so has clinical relevance, and is easy to use. It has established validity and reliability for use after stroke. It is an ordinal scale, patients scoring from 0 - 5, where 0 indicates a patient who is not able to walk or needs help of 2 therapists, and 5 indicates a patient who is independent in ambulation even on stairs. 2.4. Ability to control the trunk as measured by the Trunk Control Test: a short, simple measure of motor loss developed for use after stroke. Patients are asked to do four movements - rolling to their weak side, rolling to their strong side, sitting up from lying down and balancing in a sitting position. Each movement is scored according to ability, either 0, 12 or 25, leading to a total score out of 100. Validity and reliability have been established. |
| Secondary outcome measure(s) |
1. Onset and offset of EMG activity of antagonistic muscle groups during pedalling:
EMG activity will be recorded in quadriceps and hamstring muscles. The EMG system to be used is the Biometrics SX 230, Biometrics, UK. Baseline EMG activity in will be recorded as a voltage at 1,000Hz whilst the participant's foot is resting firmly on a box so that the leg is still and relaxed and the knee is in approximately 5 degrees of flexion, for 30 seconds. This will be undertaken for each leg in turn. EMG data (voltage) will be collected continuously during pedalling for 30 seconds at 50 rpm. EMG data will be rectified and then processed by a Technician. Baseline EMG values will be calculated as the mean ± 3 SD (standard deviations) during the 30 seconds baseline data collection period. Onset of activity in each of the four muscle groups will be defined as the time point during the 360 degree turn at which EMG voltage exceeds the mean baseline value plus 3SD for 20 data points (20 ms). Offset of activity in each of the four muscle groups will be defined as the time point during the 360 degree turn at which EMG voltage falls below the mean baseline value minus 3SD for 20 data points (20 ms). The time point for onset and offset of muscle activity in each of the four muscle groups will also be recorded as a function of the position of the pedal during the 360 degree turn as one channel of the DataLINK will be making recordings of angle of turning synchronously with EMG data. Thus in addition to timing of onset and offset of muscle activity we will also be able to relate this to the position of the pedal and during the 360 degree turn. 2. Reciprocal activation of antagonistic muscle groups during pedalling: By collection of EMG data as described above. Rectified EMG data for each antagonistic muscle pair will be analysed using the Spearman's correlation coefficient. A r value of 1.0 indicates perfect correlation and therefore complete co-contraction, no reciprocal activation, of an antagonistic muscle pair. Whereas a r value of 0 indicates no correlation and therefore complete reciprocal activation of an antagonistic muscle pair. A negative correlation therefore indicates a better level of reciprocal activation of antagonistic muscle groups. |
| Sources of funding | University of East Anglia (UK) - PhD studentship, funded by an MRC fellowship awarded to Ms Nicola Hancock |
| Trial website | |
| Publications | |
| Contact name | Prof Valerie Pomeroy |
| Address |
The Queen's Building
University of East Anglia Unviersity Drive |
| City/town | Norwich |
| Zip/Postcode | NR4 7TJ |
| Country | United Kingdom |
| Tel | +44 (0)1603 591724 |
| Fax | +44 (0)1603 593166 |
| v.pomeroy@uea.ac.uk | |
| Sponsor | University of East Anglia (UK) |
| Address |
Research and Business Services
University Drive |
| City/town | Norwich |
| Zip/Postcode | NR4 7TJ |
| Country | United Kingdom |
| Tel | +44 (0)1603 591468 |
| Fax | +44 (0)1603 591550 |
| rbs@uea.ac.uk | |
| Sponsor website: | http://www.uea.ac.uk/ |
| Date applied | 02/11/2009 |
| Last edited | 30/11/2009 |
| Date ISRCTN assigned | 30/11/2009 |
|
|
|
|
|
| © 2010 ISRCTN unless otherwise stated. | |
|
|
|
|