The main objective 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-…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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.
Secondary outcome
Secondary study parameters are fall incidence and fear of falling.
Background 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 stepadjustments 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
Study objective
The main objective 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
Study design
The current study regards a single-blind randomized controlled trial.
Intervention
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.
C-Mill training and regular treadmill walking are provided 2 or 3 times per
week in groups of 2 patients for 40 minutes and are supplemented with
conventional physiotherapy to the frequency of 5 times per week. The control
group receiving conventional physiotherapy is only provided with conventional
physiotherapy with a frequency of 5 times per week as well.
Study burden and risks
In order to reduce fall incidence in the elderly, it is import to gather
evidence on the effectiveness of intervention programs and the underlying
mechanisms.
The risks of participating in the current study are considered to be very low.
Patients of Solis Zorggroep have already been provided with regular treadmill
walking and C-Mill therapy in addition to conventional therapy. Thus, beside
randomisation little will change in terms of provided therapy.
Measures of walking ability performed in the current study will be conducted as
part of regular therapy, thus require no extra time of the participant.
Completing various questionnaires during pre-intervention, post-intervention
and retention assessments after 1 and 12 months follow up requires 30 - 50
minutes of extra time of the participant. Reporting fall incidence requires
maximal 5 minutes per day for a period of one year.
In short, the only burden of participating in the current study is the time
investment. That is, participation requires 4 times 30 - 50 minutes and maximal
5 minutes per day for a period of one year.
van der Boechorststraat 9
1081 BT Amsterdam
NL
van der Boechorststraat 9
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Fall related hip fracture
2. Age * 65 years
3. Functional Ambulation Category * 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL37842.029.11 |
OMON | NL-OMON26710 |