Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05115695 |
| Other study ID # |
hatice |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
January 30, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Kahramanmaras Sutcu Imam University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cerebral Palsy (CP) is an activity limitation, movement and posture deficiencies in early
stage of life. In 80% of these children, upper extremity (UE) dysfunctions are observed,
which leads to loss of quality of life, resulting in limited participation in activities of
daily living (ADL). When the hands are affected in UE, fine motor skills such as grasping,
writing and object manipulation are usually limited. This results in inadequate use of the
extremities in functional activities. Although all children with CP are known to be affected
by UE, studies in terms of physiotherapy and rehabilitation methods mostly focused on
children with hemiparetic CP. Similar problems are observed in children with bilateral
involvement. However, a wide variation is observed in the bimanual performance of children
with hemiparetic and bilateral involvement. Studies evaluating UE activities in children with
CP; emphasized that the inability to manipulate objects manually is one of the most important
reasons for the restriction of participation in ADLs. Physiotherapy and rehabilitation
programs include many neurodevelopmental treatment approaches including stretching,
strengthening, positioning, splinting, casting, orthosis selection and movement facilitation.
However, it is known that studies investigating the current efficacy of these treatments on
UE functions mostly focus on unilateral CP. Interventions that focus on improving UE
functions in children with bilateral CP are limited. In UE rehabilitation in bilateral CP;
states that target-focused therapy, bimanual intensive task specific training programs and
trainings such as HABIT (intensive bimanual training of the upper extremity) involving the
lower extremity have been used, but there is only evidence for HABIT-ILE (HABIT involving the
lower extremity). In the literature, it is observed that strengthening training with the
Proprioceptive Neuromuscular Facilitation (PNF) method, which makes a significant
contribution to muscle strength balance, is mostly used in lower extremity rehabilitation in
these children. In this study, in the UE rehabilitation of children with hemiparetic and
diparetic CP; in order to stimulate motor responses and improve neuromuscular control and
function, the superiority of the PNF approach applied with scapular and UE patterns over the
traditional Neurodevelopmental Therapy (NGT-Bobath) method will be determined.
Description:
European SP Surveillance (SCPE), CP subtypes according to the dominant type of tone and
movement abnormality; divided into spastic, dyskinetic and ataxic CP. Spastic type SP;
unilateral spastic (hemiparetic) and bilateral (quadriparetic and diparetic), dyskinetic SP;
defined as dystonic and choreoathetotic. Spastic type constitutes 90% of this population and
bilateral/unilateral involvement is observed in this group. In 80% of these children, upper
extremity (UE) dysfunctions are observed, which leads to loss of quality of life, resulting
in limited participation in activities of daily living (ADL).Children with CP as a result of
damage to the motor cortex and corticospinal tracts; develop abnormal movement patterns by
having difficulties in reaching, grasping and fine motor skills of UE. When the hands are
affected in UE, fine motor skills such as grasping, writing and object manipulation are
usually limited. This results in inadequate use of the extremities in functional activities.
Although all children with CP are known to be affected by UE, studies in terms of
physiotherapy and rehabilitation methods mostly focused on children with hemiparetic CP. The
most common in children with hemiparetic CP; increase in muscle tone and decreased normal
joint movement (ROM), decrease in UE muscle and grip strength, primitive grasping reflex,
loss of speed and dexterity are observed. In addition to pure motor impairment, sensorimotor
problems are also observed. Similar problems are observed in children with bilateral
involvement. However, a wide variation is observed in the bimanual performance of children
with hemiparetic and bilateral involvement. Studies evaluating UE activities in children with
CP; emphasized that the inability to manipulate objects manually is one of the most important
reasons for the restriction of participation in ADLs. In a study examining UE disorders, hand
dexterity, grip strength and functionality in ADLs in children with diparetic CP; it was
emphasized that these children also had deficiencies in dexterity, grip strength and
functions in ADL. Therefore, it has been shown that these children are also negatively
affected in terms of hand skills, coordination, UE muscle strength, grip strength, ADL and
functional skills compared to their healthy peers. Observing that UE rehabilitation in CP
remains in the background, studies on the pathophysiology and treatment of UE sequelae in the
last 5 years have come to the fore. Physiotherapy and rehabilitation programs; it includes
many neurodevelopmental treatment approaches including stretching, strengthening,
positioning, splinting, casting, orthosis selection and movement facilitation. However, it is
known that studies investigating the current efficacy of these treatments on UE functions
mostly focus on unilateral CP. Interventions that focus on improving UE functions in children
with bilateral CP are limited. In UE rehabilitation in bilateral CP; states that
target-focused therapy, bimanual intensive task specific training programs and trainings such
as HABIT (intensive bimanual training of the upper extremity) involving the lower extremity
have been used, but there is only evidence for HABIT-ILE (HABIT involving the lower
extremity). In the literature, it is observed that strengthening training with the
Proprioceptive Neuromuscular Facilitation (PNF) method, which makes a significant
contribution to muscle strength balance, is mostly used in lower extremity rehabilitation in
CP. In this study, in the UE rehabilitation of children with hemiparetic and diparetic CP; in
order to stimulate motor responses and improve neuromuscular control and function, the
superiority of the PNF approach applied with scapular and UE patterns over the traditional
Neurodevelopmental Therapy (NGT-Bobath) method will be determined. As a result of this study,
it is thought that in addition to traditional NGT-Bobath treatment approaches, muscle
strengthening with scapular pattern and upper extremity patterns of PNF can be an effective
treatment alternative in the UE rehabilitation of children with CP, and it is thought that UE
functional skills, muscle strength and trunk control of individuals will be positively
affected. Included children will be randomized by simple randomisation and divided into 2
groups. An exercise approach with PNF UE patterns will be applied to the first group for 30
minutes, 3 days a week for 6 weeks. UE rehabilitation consisting of Neurodevelopmental
Treatment (NGT-Bobath) approaches will be applied to the second group for 6 weeks, 3 days a
week, 45 minutes a day. Treatments will be carried out by the same doctor physiotherapist
investigator. Evaluations will be made twice, before and after the treatment. All assessments
will be made by a blind doctor physiotherapist investigator who is unfamiliar with the
treatment groups. Alongside the studies in the literature, this study will be the first to
compare the effectiveness of the use of UE patterns of PNF in children with hemiparetic and
diparetic CP.
