Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178653
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-12-09
Brief Title:
Two Different Treatment Modalities in Patients with Spinal Muscular Atrophy
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
Examining the Effects of Trunk Control Training and Pulmonary Rehabilitation Program in Children with Spinal Muscular Atrophy
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal Muscular Atrophy SMA is a severe neuromuscular disorder characterized by the degeneration of alpha motor neurons in the spinal cord resulting in progressive muscle atrophy and weakness particularly in proximal and axial muscles SMA causes respiratory muscle weakness recurrent infections and nocturnal hypoventilation contributing significantly to morbidity and mortality Children with SMA often display respiratory and trunk muscle weakness compared to healthy controls Our project aims to investigate the impact of pulmonary rehabilitation including inspiratory muscle training along with trunk control exercises in children with SMA The study will include 40 SMA patients aged 5-18 with maximum inspiratory capacity below 60 centimeters of water cmH2O predicted vital capacity over 25 and the ability to sit unsupported for more than 5 seconds The participants will be randomly assigned to two groups Pulmonary Rehabilitation Group Group 1 n20 and Trunk Control Training Group Group 2 n20 Group 1 will undergo breathing exercises and inspiratory muscle training IMT involving diaphragmatic pursed-lip and segmental breathing IMT will be administered with a portable device starting at appropriate resistance and consisting of 10 cycles 10 minutes each once a day with designated rest intervals Also applied by calculating 30 of the maximal inspiratory pressure MIP During weekly clinic visits the MIP value will be recalculated and the current threshold pressure value will be determined In Group 2 alongside pulmonary rehabilitation children will engage in trunk control exercises progressively increasing in difficulty focusing on pelvic control proximal stabilization and strengthening trunk and gluteal muscles All interventions will be performed in front of a mirror At the end of the 8-week intervention MIP and Maximal Expiratory Pressure MEP will be used to measure respiratory muscle performance spirometry will be used to monitor lung volume changes and Peak Cough Flow will be used to evaluate the effectiveness of cough The Trunk Control Measurement Scale the Revised Upper Extremity Module and the Childrens Quality of Life Scale will assess trunk control upper extremity functions and quality of life respectively The Hammersmith Functional Motor Scale will assess gross motor functions and the Zarit Caregiver Burden Scale will inquire about familial factors affecting the child
Detailed Description:
Spinal Muscular Atrophy SMA is a severe neuromuscular disease characterized by degenerating alpha motor neurons in the spinal cord resulting in progressive and predominantly proximal and axial muscle atrophy and weakness Its incidence is 1 in 6000 or 10000 live births The severity of the disease is highly variable It causes respiratory muscle weakness recurrent respiratory tract infections and impaired cough with nocturnal hypoventilation in children with SMA and is one of the leading causes of morbidity and mortality In addition to respiratory muscle weakness children with SMA exhibit less trunk and neck muscle activity compared to healthy controls The aim of our project is to examine the effects of pulmonary rehabilitation practices and trunk control training combined with pulmonary rehabilitation on respiratory parameters in children with SMA Forty SMA patients aged 5-18 years with a maximal inspiratory capacity of less than 60 centimeters of water cmH2O a predicted vital capacity of more than 25 and who can sit without support for more than 5 seconds will be included in the project Children with SMA will be randomly divided into 2 groups Group 1 will be the Pulmonary Rehabilitation Group n20 and Group 2 will be the Trunk Control Training Group n20 Children in group 1 will receive breathing exercises and inspiratory muscle training interventions Breathing exercises will consist of diaphragmatic breathing to increase the efficiency of inspiration and pursed lip breathing to improve oxygenation by increasing ventilation In addition during segmental breathing pressure applied by hand or with the help of a belt will provide proprioception and better expansion of the relevant regions Inspiratory muscle training will be performed with the help of a portable device The inspiratory muscle training program will begin at appropriate resistance and consist of a total of 10 cycles once a day 10 minutes each with one-minute pauses in between with 20-second pauses in between During the pulmonary exercises the oxygen levels of the children will be monitored with a pulse oximeter device attached to the participants toes In addition to pulmonary rehabilitation the children in group 2 will perform trunk control exercises of increasing difficulty which use a combination of exercises and activities for pelvic control and proximal stabilization and trunk and gluteal muscle strengthening exercises All interventions will be performed in front of the mirror Childrens fatigue levels will be determined according to the perceived exertion level The intervention of both groups will last 8 weeks Evaluation parameters will be applied before interventions begin and at the end of 8 weeks Respiratory performance and respiratory muscle strength which are among the primary measurement parameters are measured by Maximal Inspiratory Pressure and Maximal Expiratory Pressure lung capacities will be evaluated by using a spirometer device where pulmonary function tests are applied and the effectiveness of cough will be evaluated by measuring the Peak Cough Flow value Trunk Control Measurement Scale in the evaluation of trunk control Revised Upper Extremity Module for evaluation of upper extremity functions In the examination of changes in lung volumes a data record will be created using chest radiography Hammersmith Functional Motor Scale in the evaluation of gross motor functions The Childrens Quality of Life Scale will be used to evaluate the quality of life of the cases familial factors affecting children will be questioned with the Zarit Caregiver Burden Scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None