|- candidate number||10829|
|- NTR Number||NTR3222|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jan-2012|
|- Secondary IDs||NL37842.029.11 METc VUmc|
|- Public Title||Effectiveness of C-Mill training following hip fracture.|
|- Scientific Title||Functional gait rehabilitation in elderly following a fall-related hip fracture using the C-Mill: A RCT.|
|- hypothesis||Falls are common in elderly and often result in adverse consequences. The effectiveness of C-Mill training, i.e. treadmill walking with a specific emphasis on functional walking ability via constant and irregular gait modulations, obstacle crossing and speeding-up and slowing-down, on walking ability, fall incidence and fear of falling has not been studied thus far.|
It is hypothesized that C-Mill training is superior to regular treadmill walking and conventional physiotherapy in improving walking ability and reducing fall incidence and fear of falling in elderly residing in inpatient rehabilitation care after a fall-related hip fracture.
|- Healt Condition(s) or Problem(s) studied||Older adults, Falling, Hip fractures, Gait adaptability|
|- Inclusion criteria||1. Fall related hip fracture;|
2. Age > 65 years;
3. FAC > 2;
4. Expected duration of therapy: > 6 weeks;
5. Simple instructions must be understood and executed.
|- Exclusion criteria||1. Patient may not bear weight on the leg;|
2. Moderate or severe cognitive impairment (a score below 18 at the Mini Mental State Examination);
3. Severe visual deficits;
4. Contraindication to physical activity;
5. Activity tolerance below 40 minutes with rest intervals.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-jan-2012|
|- planned closingdate||1-aug-2014|
|- Target number of participants||120|
|- Interventions||1. C-Mill training, i.e. treadmill training with a specific emphasis on training gait adaptability: 2-3 times a week 40 minutes in groups of 2 patients for 6 consecutive weeks. The C-Mill training sessions are supplemented with conventional physiotherapy to a frequency of 5 times a week;|
2. Regular treadmill training : 2-3 times a week 40 minutes in groups of 2 patients for 6 consecutive weeks. Treadmill training sessions are supplemented with conventional physiotherapy to a frequency of 5 times a week;
3. Control group: Conventional physiotherapy, 5 times a week for 6 consecutive weeks.
Dose-matched control groups:
C-Mill and treadmill training sessions replace a similar dose of conventional therapy to create dose-matched control groups, i.e. all groups receive therapy with equal duration and frequency.
|- Primary outcome||Measures of balance, gait and mobility include the main study parameters. The Performance Oriented Mobility Assessment (POMA), a widely used tool for assessing mobility and fall risk in older people, is the main outcome measure in the current study. Other measurements include|
1. Functional Ambulation Category (FAC) Score;
2. Elderly Mobility Scale (EMS);
3. Nottingham Extended Activities of Daily Living (NEADL);
4. Hip Disability and Ostheoarthrisis Score (HOOS);
5. 10m walk test (10MWT);
6. 10m walk test with cognitive dual task;
7. 10m walk test with obstacle avoidance;
8. Timed Up and Go (TUG);
9. Trail Making Test (TMT).
|- Secondary outcome||Secondary study parameters are fall incidence and fear of falling. Fall incidence is monitored monthly post intervention, for a period of one year. Fear of falling is assessed using the Falls Efficacy Scale-International (FES-I).|
|- Timepoints||1. Pre-intervention (week 1);|
2. Post - intervention (week 7);
3. Retention (4 weeks post-intervention);
4. 12 month follow-up;
5. Fall incidence is monitored monthly for a period of 1 year.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. M.W. Ooijen - Kerste, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Melvyn Roerdink|
|- Sponsor/Initiator ||MOVE, Vrije Universiteit Amsterdam, Rehabilitation Centre Amsterdam|
(Source(s) of Monetary or Material Support)
|MOVE Research Institute, Vrije Universiteit Amsterdam|
|- Brief summary||Thirty percent of all community-living people over 65 years of age fall each year and fall incidence is even higher in older populations, in nursing, rehabilitation and hospital care facilities and in elderly who previously experienced an injurious fall.
Most falls are caused by trips and slips during walking and often external factors, like obstacles, are involved. Gait-related falls are thus very common events in elderly and put a large strain on the health and well-being of older adults.
Safe gait requires continuous step adjustments in order to, for example, negotiate in uneven terrain or to avoid obstacles. Earlier research reported that the ability to adjust gait during walking is often impaired in elderly. C-Mill training is
specifically developed to practice stepadjustments during walking. The effectiveness of C-Mill training, i.e. treadmill walking with a specific emphasis on functional walking ability via constant and irregular gait modulations, obstacle crossing and speeding-up and slowing-down, on walking ability, fall incidence and fear of falling has not been studied thus far.
The aim of this study is to examine the effectiveness of C-Mill training over other training for improving walking ability in elderly recovering from a fall-related hip fracture. Secondary objective is to examine the effectiveness of C-Mill
training, compared to other training, for reducing fall incidence and fear of falling.
Walking ability, fall incidence and fear of falling in a group of participants receiving 6 weeks of C-Mill training, will be compared with that of two control groups receiving either 6 weeks of dose-matched treadmill walking without a focus on training gait adjustments or dose-matched conventional physiotherapy. It is hypothesized that C-Mill training is superior to regular treadmill walking and conventional physiotherapy in improving walking ability and reducing fall incidence and fear of falling.
|- Main changes (audit trail)|
|- RECORD||3-jan-2012 - 16-jan-2012|