Hip Fracture
Conditions
Brief summary
Achieving independent ambulation is an important goal of hip fracture rehabilitation, as it is predictive of returning to the community and of future health problems. Current research regarding post-hip fracture rehabilitation is sparse. Body weight supported treadmill training (BWSTT) is a novel approach to retrain walking abilities. BWSTT may be ideal for retraining walking after hip fracture, as it is task-specific and alleviates the demands of maintaining balance while walking skills are trained. The use of the harness may provide a sense of security for the patient, facilitating walking training. The proposed project will investigate the feasibility and tolerability of BWSTT after hip fracture, and its impact on function, mobility, quality of life and fear of falling. It is hypothesized that BWSTT 3-5 times weekly in acute hip fracture patients will improve function, mobility, quality of life and reduce fear of falling.
Detailed description
Morbidity and mortality rates associated with hip fracture are enormous. Current literature regarding post-hip fracture rehabilitation is sparse. A recent Cochrane review suggested that the potential for enhancing the recovery of mobility in hip fracture patients with treadmill gait retraining warrants further research in this area. Body weight supported treadmill training (BWSTT) is a novel approach to retraining ambulation, and has been successfully implemented in other patient populations. BWSTT may be ideal for retraining gait after hip fracture, as it is task-specific and alleviates the demands of maintaining equilibrium while walking skills are trained. The objectives of the proposed pilot study are to evaluate the feasibility and tolerability of using BWSTT as a gait retraining strategy in individuals who have experienced a hip fracture, and to explore whether it can improve mobility, fear of falling and function. Participants' feedback will be sought regarding the BWSTT experience for use in planning future clinical trials, to be submitted to CIHR. Quantitative outcomes will be assessed at baseline, and after 4 weeks of training 3-5 times per week. Outcome measures include: the Lower Extremity Functional Scale, health-related quality of life (SF-36), Falls-Efficacy Scale and the 2-minute walk test. Based on previous research experience with the frail elderly, we anticipate that many patients will be receptive to rehabilitation in the form of BWSTT. We hypothesize that BWSTT after hip fracture will result in significant gains in ambulatory capacity, as well as improvements in quality of life and functional independence. In addition, we anticipate that BWSTT will prove to be a feasible and effective gait retraining strategy.
Interventions
hip fracture patients walk on a treadmill with body weight support
Sponsors
Study design
Eligibility
Inclusion criteria
* Able to follow 2-step commands * Stable inter-trochanteric fracture, where fixation is deemed by surgeon to be adequate, OR sub-capital fracture having undergone bipolar hemi-arthroplasty * Able to stand and take a few steps with the help of an assistive device i.e. parallel bars, walker, or cane
Exclusion criteria
* Able to walk without assistive devices * Hip, knee or ankle surgery prior to hip fracture * Inability to understand instructions or give informed consent * Uncontrolled cardiovascular disease or hypertension, diabetes, neuromuscular disease or other musculoskeletal disease such as rheumatoid arthritis, Uncontrolled pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up | 3 months | Compliance to BWSTT only, |
Secondary
| Measure | Time frame |
|---|---|
| Timed up and Go | discharge |
| Falls Self Efficacy | discharge |
| 2 Minute Walk Test | discharge |
| Lower Extremity Functional Scale | discharge |
Countries
Canada
Participant flow
Recruitment details
Patients treated for a hip fracture by orthopedic surgeons and admitted to the inpatient rehabilitation floor of a teaching hospital between September 2006 and November 2007 were considered for participation. A break in recruitment was implemented from November to early January to avoid variation in physiotherapy care related to holidays.
Participants by arm
| Arm | Count |
|---|---|
| BWSTT Body weight supported treadmill training | 14 |
| Control Usual care | 7 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline to Discharge | MRSA | 1 | 0 |
| Baseline to Discharge | not interested | 1 | 0 |
| Baseline to Discharge | Physician Decision | 0 | 1 |
| Baseline to Discharge | Protocol Violation | 0 | 1 |
| Follow-up | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | BWSTT | Total | Control |
|---|---|---|---|
| 2 Minute Walk Test time | 18.7 metres STANDARD_DEVIATION 18.9 | 20.6 metres STANDARD_DEVIATION 17.3 | 23.6 metres STANDARD_DEVIATION 15.3 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 21 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 79.9 years STANDARD_DEVIATION 7 | 81.2 years STANDARD_DEVIATION 7 | 83.7 years STANDARD_DEVIATION 8.6 |
| Falls Self-efficacy Scale | 22.4 units on a scale STANDARD_DEVIATION 9.2 | 22.2 units on a scale STANDARD_DEVIATION 8.7 | 22.0 units on a scale STANDARD_DEVIATION 8.2 |
| Lower Extremity Functional Score | 16.6 units on a scale STANDARD_DEVIATION 8 | 19.7 units on a scale STANDARD_DEVIATION 11.9 | 25.7 units on a scale STANDARD_DEVIATION 16.5 |
| Sex: Female, Male Female | 12 Participants | 18 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
| Timed up and go time | 73.9 seconds STANDARD_DEVIATION 29.1 | 64.8 seconds STANDARD_DEVIATION 27.8 | 45.6 seconds STANDARD_DEVIATION 10.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 5 |
| serious Total, serious adverse events | 0 / 12 | 0 / 5 |
Outcome results
Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up
Compliance to BWSTT only,
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BWSTT | Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up | # with at least 60% compliance | 6 Participants |
| BWSTT | Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up | # agreed to participate | 14 Participants |
| BWSTT | Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up | #returned for 3 month followup | 10 Participants |
2 Minute Walk Test
Time frame: discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BWSTT | 2 Minute Walk Test | 70.6 metres | Standard Deviation 17.3 |
| Control | 2 Minute Walk Test | 79.4 metres | Standard Deviation 17.9 |
Falls Self Efficacy
Time frame: discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BWSTT | Falls Self Efficacy | 17.7 units on a scale | Standard Deviation 6.6 |
| Control | Falls Self Efficacy | 12.8 units on a scale | Standard Deviation 4.4 |
Lower Extremity Functional Scale
Time frame: discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BWSTT | Lower Extremity Functional Scale | 35.3 units on a scale | Standard Deviation 7.5 |
| Control | Lower Extremity Functional Scale | 46.4 units on a scale | Standard Deviation 7.2 |
Timed up and Go
Time frame: discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BWSTT | Timed up and Go | 25.2 seconds | Standard Deviation 7 |
| Control | Timed up and Go | 20.7 seconds | Standard Deviation 5 |