Osteoarthritis, KneeNCT03921801
Effects of Improved Calf Muscle Function on Gait, Balance and Joint Loading in Older Adults
A study testing Gait retraining and Gait retraining + strength training in people with Osteoarthritis, Knee and Mobility Limitation, run by University of Eastern Finland at 1 site in Finland.
Trial summary
This study investigates the role of calf muscle function in gait performance, balance and knee joint loading. Previous studies have linked age-related loss of calf muscle function with impairments in gait performance and balance, and increased loading of the areas of the knee joint that are susceptible to the… Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Mobility Limitation, Accidental Fall
- What is being tested?
- Gait retraining and Gait retraining + strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 13 Apr 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age between 65 and 75
Who cannot join
- dependent living status
- not able to walk without an assistive device or for 30 min without stopping
- diagnosed neurological disease or joint disorder and pain during walking
- surgery on lower extremities
- current musculoskeletal injury
- previous cardiovascular event or symptoms during exercise (acute ECG change, coronary disease, symptomatic arrhythmia, symptomatic coronary stenosis, heart failure, myocarditis, pericarditis, pulmonary embolism, pulmonary infarct, artery bulge or rupture risk)
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- body mass index <18 or >35 kg/m2
- contraindications for magnetic resonance imaging
- Mini Mental State Examination score of 23 points and lower
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Plantarflexor Muscle Function to Alleviate Decline in Mobility, Loss of Balance and Detrimental Knee Joint Loading in Older Adults
This study investigates the role of calf muscle function in gait performance, balance and knee joint loading.
Previous studies have linked age-related loss of calf muscle function with impairments in gait performance and balance, and increased loading of the areas of the knee joint that are susceptible to the development of osteoarthritis. In this study, an exercise intervention targeting structural and neural aspects of impaired calf muscle function with ageing is utilized. The intervention lasts 8 weeks and includes either biofeedback training using electromyography to alter muscle activation patterns or a combination of biofeedback training and strength training for the calf muscle to modify calf function during walking. The study will test whether the intervention improves walking speed, reduces the metabolic cost of walking, improves standing balance and reduces knee joint loading.
- Conditions
- Osteoarthritis, Knee, Mobility Limitation, Accidental Fall
- Being tested
- Gait retraining, Gait retraining + strength training
- Keywords
- Osteoarthritis, Knee, Achilles tendon, Triceps surae, Balance, Electromyography, Biofeedback, Strength training, Gait, Walking
- Medical subject headings
- Osteoarthritis, Knee, Mobility Limitation, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait retrainingOther
Gait retraining using real-time electromyography biofeedback performed once per week for eight weeks.
During the gait retraining session the participant is walking on a treadmill while receiving information on calf muscle activation. A single session includes five bouts of walking each lasting for 5 minutes. During the first bout, the participant is receiving feedback (visual and auditive) on soleus muscle activation with the aim to increase it by 20% from their normal walking. During the second bout, the participant is receiving feedback (visual and auditive) on medial gastrocnemius muscle activation with the aim to decrease it by 20% from their normal walking. During the last three bouts, the participant is receiving feedback (visual and auditive) on the soleus to medial gastrocnemius muscle activation ratio with the aim to increase it by 20% from their normal walking. If hitting the target, the aim is increased by 5% for the subsequent bout.
Gait retraining + strength trainingOther
Gait retraining using real-time electromyography biofeedback performed once per week and home-based calf muscle strength training performed three times per week for eight weeks.
The gait retraining is identical to the one intervention described for the intervention group "Gait retraining".
The strength training is performed three times per week except for the first week in which it is performed two times. The session contained a warm-up (3x10 repetitions of two-legged heel raises) and maximal isometric calf muscle contractions. The maximal contractions are performed using a custom device with the ankle in dorsiflexion and the knee flexed by 100-120 degrees. Three sets of 10 repetitions (3-second contraction and 3-second rest) are performed with both legs and with maximal effort and 1-minute rest between the sets.
| Study group | Role | What they receive |
|---|---|---|
| Gait retraining | Active comparator | 8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback. Receives: Other: Gait retraining |
| Gait retraining + strength training | Experimental | 8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback and home-based strength training session for plantarflexor muscles three times per week. Receives: Other: Gait retraining + strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in knee joint loading
Change in tibiofemoral compressive loading during walking estimated using musculoskeletal modeling and simulation. Loading is calculated separately for medial and lateral compartments of the tibiofemoral joint.
Measured: within 1 weeks after intervention
Secondary outcomes (11)
Change from baseline in energy cost of walking
Assessed using indirect calorimetry.
Measured: within 1 weeks after intervention
Change from baseline in standing balance
Sway during standing measured using a force plate with eyes open and closed
Measured: within 1 weeks after intervention
Change from baseline in Achilles tendon stiffness
Achilles tendon stiffness evaluated using combination of ultrasonography, motion analysis and force measurements.
Measured: within 1 weeks after intervention
Change from baseline in gait kinematics
Time series of lower limb joint angles during walking stride assessed using motion capture system and inverse kinematics.
Measured: within 1 weeks after intervention
Change from baseline in joint moments during walking
Time series of lower limb joint moments during walking stride assessed using inverse dynamics based on motion capture system and instrumented treadmill data.
Measured: within 1 weeks after intervention
Change from baseline in joint powers during walking
Time series of lower limb joint powers during walking stride assessed using inverse dynamics based on motion capture system and instrumented treadmill data.
Measured: within 1 weeks after intervention
Change from baseline in distribution of joint work during walking
Distribution of total positive lower limb work between the joints during walking assessed using inverse dynamics based on motion capture system and instrumented treadmill data.
Measured: within 1 weeks after intervention
Change from baseline in muscle-tendon function during walking
Muscle fascicle kinematics measured using dynamics ultrasonography during walking.
Measured: within 1 weeks after intervention
Change from baseline in soleus to gastrocnemius muscle activation ratio
Relative activation of soleus to medial gastrocnemius measured using electromyography.
Measured: within 1 weeks after intervention
Change from baseline in walking speed
Preferred and maximal walking speed.
Measured: within 1 weeks after intervention
Change from baseline in muscle strength
Maximal isometric muscle strength in ankle plantarflexion and knee extension and flexion.
Measured: within 1 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start13 Apr 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty older adults will be recruited and randomized into two groups. The other groups receive an intervention including strength training and gait retraining lasting 8 weeks while the other group receives only the gait retraining. Outcome measures are obtained before and after the intervention period.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauri Stenroth, University of Eastern Finland
- Investigators
- Lauri Stenroth, PhD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921801
- Sponsor's protocol ID
- LS_Plantarflex
- Status last verified
- Mar 2024
- First submitted
- 10 Dec 2018
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained during the study will be shared with other researcher after the results have been published. Details of the data will be updated later.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Plantarflexor Muscle Function to Alleviate Decline in Mobility, Loss of Balance and Detrimental Knee Joint Loading in Older Adults
- ClinicalTrials.gov ID
- NCT03921801
- Acronym / sponsor ID
- LS_Plantarflex
- Conditions
- Osteoarthritis, Knee, Mobility Limitation, Accidental Fall
- Keywords
- Osteoarthritis, Knee, Achilles tendon, Triceps surae, Balance, Electromyography, Biofeedback, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the role of calf muscle function in gait performance, balance and knee joint loading.
Previous studies have linked age-related loss of calf muscle function with impairments in gait performance and balance, and increased loading of the areas of the knee joint that are susceptible to the development of osteoarthritis. In this study, an exercise intervention targeting structural and neural aspects of impaired calf muscle function with ageing is utilized. The intervention lasts 8 weeks and includes either biofeedback training using electromyography to alter muscle activation patterns or a combination of biofeedback training and strength training for the calf muscle to modify calf function during walking. The study will test whether the intervention improves walking speed, reduces the metabolic cost of walking, improves standing balance and reduces knee joint loading.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Thirty older adults will be recruited and randomized into two groups. The other groups receive an intervention including strength training and gait retraining lasting 8 weeks while the other group receives only the gait retraining. Outcome measures are obtained before and after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Gait retraining | Active comparator | Other: Gait retraining8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback. |
| Gait retraining + strength training | Experimental | Other: Gait retraining + strength training8-week intervention. Intervention includes weekly gait retraining sessions with real-time electromyography biofeedback and home-based strength training session for plantarflexor muscles three times per week. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age between 65 and 75
Key exclusion criteria (9 listed)
- dependent living status
- not able to walk without an assistive device or for 30 min without stopping
- diagnosed neurological disease or joint disorder and pain during walking
- surgery on lower extremities
- current musculoskeletal injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait retrainingGait retraining using real-time electromyography biofeedback performed once per week for eight weeks. During the gait retraining session the participant is walking on a treadmill while receiving information on calf muscle activation. A single session includes five bouts of walking each lasting for 5 minutes. During the first bout, the participant is receiving feedback (visual and auditive) on soleus muscle activation with the aim to increase it by 20% from their normal walking. During the second bout, the participant is receiving feedback (visual and auditive) on medial gastrocnemius muscle activation with the aim to decrease it by 20% from their normal walking. During the last three bouts, the participant is receiving feedback (visual and auditive) on the soleus to medial gastrocnemius muscle activation ratio with the aim to increase it by 20% from their normal walking. If hitting the target, the aim is increased by 5% for the subsequent bout. | Other | Gait retraining |
| Gait retraining + strength trainingGait retraining using real-time electromyography biofeedback performed once per week and home-based calf muscle strength training performed three times per week for eight weeks. The gait retraining is identical to the one intervention described for the intervention group "Gait retraining". The strength training is performed three times per week except for the first week in which it is performed two times. The session contained a warm-up (3x10 repetitions of two-legged heel raises) and maximal isometric calf muscle contractions. The maximal contractions are performed using a custom device with the ankle in dorsiflexion and the knee flexed by 100-120 degrees. Three sets of 10 repetitions (3-second contraction and 3-second rest) are performed with both legs and with maximal effort and 1-minute rest between the sets. | Other | Gait retraining + strength training |
Primary outcome
Change from baseline in knee joint loading
Time frame: within 1 weeks after intervention
Change in tibiofemoral compressive loading during walking estimated using musculoskeletal modeling and simulation. Loading is calculated separately for medial and lateral compartments of the tibiofemoral joint.
11 secondary outcomes
Change from baseline in energy cost of walking
Time frame: within 1 weeks after intervention
Change from baseline in standing balance
Time frame: within 1 weeks after intervention
Change from baseline in Achilles tendon stiffness
Time frame: within 1 weeks after intervention
Change from baseline in gait kinematics
Time frame: within 1 weeks after intervention
Change from baseline in joint moments during walking
Time frame: within 1 weeks after intervention
Change from baseline in joint powers during walking
Time frame: within 1 weeks after intervention
Change from baseline in distribution of joint work during walking
Time frame: within 1 weeks after intervention
Change from baseline in muscle-tendon function during walking
Time frame: within 1 weeks after intervention
Change from baseline in soleus to gastrocnemius muscle activation ratio
Time frame: within 1 weeks after intervention
Change from baseline in walking speed
Time frame: within 1 weeks after intervention
Change from baseline in muscle strength
Time frame: within 1 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. Data obtained during the study will be shared with other researcher after the results have been published. Details of the data will be updated later.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauri Stenroth, PhD principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait retraining and Gait retraining + strength training in people with Osteoarthritis, Knee and Mobility Limitation, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in knee joint loading (time frame: within 1 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.