Limb Immobilization for Muscle Atrophy

Overseen By Micah Drummond, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Anticoagulants, Corticosteroids, Androgens

Disqualifiers: Cardiovascular, Endocrine, Kidney, Vascular, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an interventional study enrolling healthy individuals aged 18-35 and 60-85 to understand the recovery of muscle health following a period of inactivity. The enrollment goal is 45 participants. The study will occur over the course of 1-2 months where participants will undergo testing before and after a 2-week limb immobilization period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but certain medications like anticoagulants and chronic systemic corticosteroids are not allowed. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Limb immobilization, Splinting, Casting, Coaptation for muscle atrophy?

The research on night splints for Duchenne muscular dystrophy suggests that similar treatments can help maintain motor function, which may imply potential benefits for muscle atrophy management. ^{1 2 3 4 5}

Is limb immobilization generally safe for humans?

Limb immobilization, such as casting and splinting, is generally safe but can have risks like stiffness, pressure sores, and compartment syndrome (a painful condition caused by pressure buildup). These risks are higher if the cast is applied by someone inexperienced, and certain groups, like young children or those with certain medical conditions, may be at higher risk for complications. ^{6 7 8 9 10}

How does limb immobilization differ from other treatments for muscle atrophy?

Limb immobilization, such as casting or splinting, is unique because it physically restricts movement to induce muscle atrophy, which can be useful for studying the condition. Unlike other treatments that may focus on preventing atrophy, this method intentionally causes it to understand and manage muscle loss better. ^{6 8 11 12 13}

Research Team

Micah Drummond

Principal Investigator

University of Utah

Eligibility Criteria

Healthy individuals aged 18-35 and 60-85 can join this study on muscle health recovery after inactivity. Participants must be able to consent and live independently. Exclusions include a risk of blood clots, certain blood disorders, implanted electronic devices, recent steroid use, hormone treatments, pregnancy, staff under the investigator's supervision, or any condition deemed exclusionary by the lead researcher.

Inclusion Criteria

Ability to sign informed consent

Free-living, prior to admission

Exclusion Criteria

I am currently on blood thinner medication.

I have had a stroke that affected my ability to move.

I have a history of thyroid or diabetes issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-testing

Participants undergo blood screening, oral glucose tolerance test, and receive a step activity monitor

1 week

1 visit (in-person)

Immobilization

Participants undergo a 2-week leg immobilization period

2 weeks

3 visits (in-person)

Recovery

Participants undergo testing including biopsy, blood draw, body composition scan, MRI, and muscle strength testing

1 week

2 visits (in-person)

Follow-up

Participants are monitored for recovery of muscle health after immobilization

1 week

1 visit (in-person)

Treatment Details

Interventions

• Limb immobilization

Trial Overview The trial studies how muscles recover from a period of not being used (limb immobilization) over 1-2 months in two age groups. It involves testing before and after keeping a limb still for two weeks among 45 participants to understand muscle atrophy during disuse and subsequent recovery.

Participant Groups

Group I: Limb immobilization Experimental Treatment 1 Intervention

Participants will undergo a 2-week leg immobilization period

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

The study assessed the reliability of four tests (Cervical Rotation, Supine Angle of Trunk Rotation, Hip Extension, and Pelvic Obliquity) in evaluating musculoskeletal issues in 30 children with spinal muscular atrophy (SMA), showing excellent reliability for both intraobserver and interobserver assessments.

These reliable tests can help detect early musculoskeletal changes in SMA patients, which is crucial for monitoring treatment effectiveness and guiding rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of four tests to assess body posture and the range of selected movements in individuals with spinal muscular atrophy. Stępień, A., Jędrzejowska, M., Guzek, K., et al.[2020]

A systematic review of 16 studies found low-grade evidence that casting can temporarily increase ankle range of motion, orthoses can improve gait parameters while worn, and supported standing programs can enhance bone mineral density in children with neuromuscular disabilities.

Overall, the evidence for the effectiveness of stretching interventions in improving body functions, preventing contractures, or enhancing activity and participation in these children is limited and inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Stretch Interventions for Children With Neuromuscular Disabilities: Evidence-Based Recommendations. Craig, J., Hilderman, C., Wilson, G., et al.[2018]

In a study of 14 non-ambulant adolescents and young adults with spinal muscular atrophy (SMA), participants reported that muscle weakness was a greater challenge than contractures, indicating that they had adapted to their condition over time.

Participants found contracture management helpful when it aligned with meaningful goals, and their views on treatment could change if there was a promise of improved motor function from disease-modifying therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of contractures on daily functioning in adolescents with spinal muscular atrophy: a qualitative study. Oude Lansink, ILB., Gorter, JW., van der Pol, WL., et al.[2023]

In a study of nine boys under 11 years old with Duchenne muscular dystrophy (DMD), those who wore night splints regularly showed a significant improvement in left ankle dorsiflexion angles after one year.

The results suggest that consistent use of night splints may help improve or maintain standing motor function in patients with DMD, although other motor function indicators showed only trends toward improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of wearing night splints for one year on the standing motor function of patients with Duchenne muscular dystrophy. Nishizawa, H., Matsukiyo, A., Shiba, N., et al.[2020]

Surgical correction of deformities and the use of braces can significantly improve the quality of life for children with muscular dystrophy by enhancing their self-reliant skills and maintaining an upright posture.

These interventions can help prolong independent walking, delaying the need for a wheelchair or bed confinement, which is crucial for the overall rehabilitation of patients with muscular dystrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopedic correction of musculoskeletal deformity in muscular dystrophy. Siegel, IM.[2006]

Using an ankle-foot orthosis (AFO) for immobilization over 6 weeks significantly reduces loss of range of motion, muscle strength, and atrophy compared to traditional short-leg cast (SLC) immobilization.

AFOs offer additional benefits such as fewer cast changes, cost savings, easier assessment of functional improvement, and better adjustments for swelling and atrophy during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A physiological comparison of the short-leg walking cast and an ankle-foot orthosis walker following 6 weeks of immobilization. Neumann, H., O'Shea, P., Nielson, JP., et al.[2022]

Internal fixation has become the preferred method for managing fractures, leading to less training for orthopedic surgeons in casting techniques, which can increase the risk of complications.

Patients at high risk for complications from casting, such as those who are comatose, very young, or have developmental delays, require careful application of casts and splints using recommended materials and methods to prevent issues like stiffness and compartment syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cast and splint immobilization: complications. Halanski, M., Noonan, KJ.[2022]

Plaster casts have been a crucial method for treating fractures and musculoskeletal conditions for centuries, with a significant historical evolution in materials and techniques, including the introduction of plaster of Paris in 1798 and synthetic casting tapes in the 1970s.

Despite advancements in surgical techniques, plaster casts and splints continue to be important for immobilization, but they require careful application to avoid complications like burns, especially when using multiple layers or high water temperatures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plaster: our orthopaedic heritage: AAOS exhibit selection. DeMaio, M., McHale, K., Lenhart, M., et al.[2022]

In a study involving 100 pediatric patients with upper extremity fractures, the customized 'Providence' Pedi Cast-Sling (PPCS) significantly improved patient and parent satisfaction compared to a standard sling, with higher convenience and compliance reported.

Patients using the PPCS wore the sling for an average of 10.3 hours a day, compared to only 5.9 hours for those with the standard sling, indicating that the PPCS encourages better adherence to immobilization after casting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial of a Customized Cast-Sling Versus Standard Cast and Sling. Cruz, AI., DeFroda, SF., Gil, JA., et al.[2019]

In a study of 50 children and teenagers with wrist and forearm fractures, significant bone mineral density (BMD) loss was observed immediately after cast removal, but full recovery was achieved by 6 months post-fracture.

The research indicated that while there was a rapid reversal of bone mass loss with resumed mobilization, the presence of healing bone callus could affect the interpretation of BMD measurements at the fracture site even 18 months later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of Bone Mineral Mass After Upper Limb Fractures in Children and Teenagers. Maggio, ABR., Martin, X., Tabard-Fougère, A., et al.[2019]

The Velcro immobilization method effectively induces muscle atrophy in mice, producing results comparable to traditional cast immobilization, but with reduced procedure time and fewer adverse effects.

This new method minimizes complications such as skin injury and edema, making it a safer and more efficient option for studying muscle atrophy in research and potentially in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new model of skeletal muscle atrophy induced by immobilization using a hook-and-loop fastener in mice. Aihara, M., Hirose, N., Katsuta, W., et al.[2020]

Transcutaneous electrical stimulation significantly reduces muscle atrophy and strength loss in patients after knee surgery compared to standard isometric training, as shown in a study of 20 patients over two weeks.

Patients receiving electrostimulation experienced quicker recovery, including earlier walking without crutches, improved knee motion, reduced swelling, and lower pain medication usage, indicating enhanced rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous muscle stimulation to retard disuse atrophy after open meniscectomy. Gould, N., Donnermeyer, D., Gammon, GG., et al.[2006]

In a study of 40 patients with one leg immobilized in a cast for 3 to 12 weeks, significant changes in the quadriceps muscle were observed, indicating muscle atrophy due to immobilization.

Even after 24 weeks of remobilization following 12 weeks of immobilization, the muscle mass did not fully recover, suggesting long-term effects of immobilization on muscle health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quadriceps femoris muscle during immobilisation and remobilisation (author's transl)]. Rosemeyer, B., Stürz, H.[2006]

References

1. England pubmed.ncbi.nlm.nih.gov

Reliability of four tests to assess body posture and the range of selected movements in individuals with spinal muscular atrophy. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Stretch Interventions for Children With Neuromuscular Disabilities: Evidence-Based Recommendations. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Impact of contractures on daily functioning in adolescents with spinal muscular atrophy: a qualitative study. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

The effect of wearing night splints for one year on the standing motor function of patients with Duchenne muscular dystrophy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Orthopedic correction of musculoskeletal deformity in muscular dystrophy. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

A physiological comparison of the short-leg walking cast and an ankle-foot orthosis walker following 6 weeks of immobilization. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cast and splint immobilization: complications. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Plaster: our orthopaedic heritage: AAOS exhibit selection. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial of a Customized Cast-Sling Versus Standard Cast and Sling. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Recovery of Bone Mineral Mass After Upper Limb Fractures in Children and Teenagers. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

A new model of skeletal muscle atrophy induced by immobilization using a hook-and-loop fastener in mice. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous muscle stimulation to retard disuse atrophy after open meniscectomy. [2006]

13. Germany pubmed.ncbi.nlm.nih.gov

[Quadriceps femoris muscle during immobilisation and remobilisation (author's transl)]. [2006]