Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06348667 |
| Other study ID # |
3184794 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 7, 2024 |
| Est. completion date |
June 10, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
University of Valencia |
| Contact |
Rodrigo Martín-San Agustín, Doctor |
| Phone |
+34 963 983 853 |
| Email |
rodrigo.martin[@]uv.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to assess the effectiveness of adding specific Blackboard
Training (BB) exercises to conventional physiotherapy in improving foot and ankle parameters
essential for fall prevention among older adults.
The main questions it aims to answer are:
1. Can the addition of BB exercises improve ankle dorsiflexion mobility?
2. Can the addition of BB exercises enhance single-leg stability and control of
mediolateral displacement of the center of pressure?
Participants will be divided into control and intervention groups. Both groups will receive
their usual conventional physiotherapy exercises. The intervention group will undergo a
5-week program comprising 10 sessions of BB exercises targeting ankle mobility and balance.
Participants will be asked to:
- Perform 3 sets of 15 repetitions for assisted ankle dorsiflexion mobility.
- Engage in 5 rounds of 40-second balance exercises using the BB.
Researchers will compare the intervention group's outcomes with those of the control group to
determine the effectiveness of adding BB exercises in improving foot and ankle parameters
related to fall prevention.
Description:
Age serves as a predictor of single-leg stability, ankle dorsiflexion range, and plantar
flexor strength loss in older adults. Various factors contribute to their heightened risk of
falls, such as foot pain, reduced ankle and big toe mobility, increased pressure on specific
foot regions during stance, and greater mediolateral displacement of center of pressure.
Exercise interventions have strong support in the field of fall prevention. In turn, foot
flexor muscle fatigue has been associated with increased displacement of the center of
pressures, so training of this muscles may be useful. While several fall prevention
strategies for older adults have shown positive outcomes, some studies face limitations like
small sample sizes or insufficient improvement in static balance, possibly due to low
exercise intensity and specificity.
The conventional use of instability devices like the BOSU, Wobble board, Airex, or Swiss ball
presents challenges in older adult contexts due to their bulkiness and indiscriminate
instability. Hence, a specific instability training approach could be interesting to address
fall risk factors.
This study proposes a Blackboard Training (BB) exercise intervention for older adults, known
for its portability, small size, and adaptability, comparable in effectiveness to traditional
devices like the BOSU or Wobble board in activating Peroneus longus muscle, essential for
single-leg stability.
Participants will be divided into control and intervention groups, both receiving their usual
conventional physiotherapy exercises. The intervention group will undergo a 5-week program
comprising 10 sessions. Measurements will be taken pre-study, one week prior, post-study
completion, and at a follow-up one month later to assess the duration of observed changes.
Each session, lasting 50 minutes, will include a warm-up, BB exercises targeting ankle
mobility and balance, and a cool-down. Safety precautions, such as parallel bars for support,
will be provided during balance exercises. Specific BB exercises will be: 3 sets of 15
repetitions for assisted ankle dorsiflexion mobility and 5 rounds of 40-second balance
exercises.
The analyzed variables will include ankle and big toe range of motion (ROM), the Lunge test,
bipedal and monopodal stabilometry, strength of ankle and foot, the Timed-Up-and-Go test and
the Single-leg Stance Test.
The hypothesis is that adding specific BB training to conventional physiotherapy for older
adults can improve foot and ankle parameters essential for fall prevention, including ankle
dorsiflexion and single-leg support. Improvement in ankle dorsiflexion and better control of
mediolateral displacement of the center of pressure are expected outcomes.
