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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04574934
Other study ID # P.T.REC/012/002574
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date October 1, 2020

Study information

Verified date September 2020
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to assess the efficacy of aquatic therapy on pulmonary functions in patients with muscular dystrophy.


Description:

Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening and breakdown of skeletal muscles over time. The disorders differ in which muscles are primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin. Many people will eventually become unable to walk. Some types are also associated with problems in other organs. The muscular dystrophy group contains thirty different genetic disorders that are usually classified into nine main categories or types.

The signs and symptoms consistent with muscular dystrophy are: progressive muscular wasting, poor balance, scoliosis (curvature of the spine and the back), progressive inability to walk, waddling gait, Calf deformation, Limited range of movement,respiratory difficulty, cardiomyopathy and muscle spasms


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 4 Years to 40 Years
Eligibility Inclusion Criteria:

- Their age will ranging from four to forty years.

- Patients participated in this study will from both sexes.

- All patients will able to walk supported or unsupported by the therapist.

- All patients will able to follow the instructions during testing and training.

- All patients had no fixed contractures or deformities at the lower limb.

Exclusion Criteria:

- Patients with visual or auditory problems.

- Patients with structural joints deformities of the lower limbs.

- Patients with convulsions and fixed contractures.

- Uncooperative Patient.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
aquatic therapy
Aquatic therapy refers to water-based treatments or exercises of therapeutic intent, in particular for relaxation, fitness, and physical rehabilitation. Treatments and exercises are performed while floating, partially submerged, or fully submerged in water. Many aquatic therapy procedures require constant attendance by a trained therapist and are performed in a specialized temperature-controlled pool. Rehabilitation commonly focuses on improving the physical function associated with illness, injury, or disability

Locations

Country Name City State
Egypt South Valley University, Faculty of Physical Therapy Qina Qina

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Abresch RT, Carter GT, Han JJ, McDonald CM. Exercise in neuromuscular diseases. Phys Med Rehabil Clin N Am. 2012 Aug;23(3):653-73. doi: 10.1016/j.pmr.2012.06.001. Review. — View Citation

Bach JR, Martinez D. Duchenne muscular dystrophy: continuous noninvasive ventilatory support prolongs survival. Respir Care. 2011 Jun;56(6):744-50. doi: 10.4187/respcare.00831. Epub 2011 Feb 11. — View Citation

Eagle M. Report on the muscular dystrophy campaign workshop: exercise in neuromuscular diseases Newcastle, January 2002. Neuromuscul Disord. 2002 Dec;12(10):975-83. — View Citation

Fowler WM Jr. Role of physical activity and exercise training in neuromuscular diseases. Am J Phys Med Rehabil. 2002 Nov;81(11 Suppl):S187-95. Review. — View Citation

Khirani S, Ramirez A, Aubertin G, Boulé M, Chemouny C, Forin V, Fauroux B. Respiratory muscle decline in Duchenne muscular dystrophy. Pediatr Pulmonol. 2014 May;49(5):473-81. doi: 10.1002/ppul.22847. Epub 2013 Jul 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Forced Vital Capacity (FVC) Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry. Forced Vital Capacity (FVC) will be assessed at day 0.
Primary Forced Vital Capacity (FVC) Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry. Forced Vital Capacity (FVC) will be assessed at day 90.
Primary Forced Expiratory Volume (FEV1) Forced expiratory volume in one second (FEV1) is a measurement of your ability to expel air from your lungs. More specifically, and as its name suggests, it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible. Forced Expiratory Volume (FEV1) will be assessed at day 0.
Primary Forced Expiratory Volume (FEV1) Forced expiratory volume in one second (FEV1) is a measurement of your ability to expel air from your lungs. More specifically, and as its name suggests, it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible. Forced Expiratory Volume (FEV1) will be assessed at day 90.
Primary Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease.[2][3] It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).[4] The result of this ratio is expressed as FEV1%. Normal values are approximately 75%.[5] Predicted normal values can be calculated online and depend on age, sex, height, and ethnicity as well as the research study that they are based upon. A derived value of FEV1% is FEV1% predicted, which is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex, and body composition. Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 0.
Primary Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease.[2][3] It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).[4] The result of this ratio is expressed as FEV1%. Normal values are approximately 75%.[5] Predicted normal values can be calculated online and depend on age, sex, height, and ethnicity as well as the research study that they are based upon. A derived value of FEV1% is FEV1% predicted, which is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex, and body composition. Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 90.
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