Effects of Task-oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control, Balance, and Gross Motor Function in Children with Spastic Diplegic Cerebral Palsy: A Single-blinded Randomized Clinical Trial.

PURPOSE: To examine the effects of task-oriented activities based on neurodevelopmental therapy (TOA-NDT) principles on trunk control, balance, and gross motor function in children with spastic diplegic cerebral palsy (SDCP).
MATERIALS AND METHODS: Forty-four children with SDCP, aged 7-15 years, were recruited to participate in the randomized clinical trial. After random allocation, twenty-two (n = 22) children with SDCP participated in TOA-NDT principles and twenty-two (n = 22) in conventional physiotherapy (CPT) program. Each group underwent the treatment for a duration of 60min per day, 6 days a week for 6 weeks. Gross motor function measure-88 (GMFM-88), postural assessment scale (PAS), pediatric balance scale (PBS), and trunk impairment scale (TIS) were the outcome measures used to document the pre- and post-intervention effect.
RESULTS: The mean difference of GMFM-88, PAS, PBS, and TIS was 8.53 (5.84-11.23), 0.90 (5.84-11.23), 4.86 (2.93-6.79), and 1.45 (0.30-2.60), respectively. TOA-NDT group showed improvement in all the outcomes.
CONCLUSION: TOA-NDT principles are more beneficial in improving the trunk control, balance, and gross motor function parameters than CPT. Copyright:

Introduction and Purpose

Cerebral palsy (CP) is one of the leading causes of chronic disability in pediatric population. The incidence of CP in India is estimated to be approximately three cases per 1000 live births and the prevalence rates of spastic diplegia in Jalandhar District of Punjab, India, was reported as 44%.[1] Among the various types of CP, spastic diplegia is the most prevalent type with a greater involvement of the lower extremities than the upper extremities, majorly affecting functional performance and gait. Many studies have shown that the postural muscles are discoordinated in children with diplegic CP.[2345] Trunk control abnormalities are a major limitation to the motor development in children with diplegic CP.[367] Trunk instability in children with diplegic CP is evident from the greater oscillations of the center of pressure observed in the anteroposterior and mediolateral directions, which leads to alteration in balance.[8910] Delayed gross motor function development is very common in children with diplegic CP; it has been related to functional outcomes such as activities of daily living.[2] Poor walking abilities and movement management skill are common in children with diplegic CP.

Neurodevelopmental therapy (NDT) is the most widely used therapeutic approach in the treatment of children with CP.[11] It aims to target the central nervous and neuromuscular systems and teaches the brain to improve motor efficiency and obtain maximal functional independency by facilitating typical postural-controlled movements.[1213] Task-oriented training, one of the principles of NDT, has shown to be effective and efficient in improving the performance, promoting intensive, meaningful, and goal-oriented training.[111213] Several studies have claimed the effectiveness of NDT in children with spastic diplegic CP (SDCP).[1112131415161718] To the best of our knowledge, there is a dearth of literature on the effect of NDT on trunk control in children with CP. Therefore, this study aimed to study the effect of task-oriented training on trunk control, balance, posture, and gross motor function in children with SDCP aged 7 and 15 years.

Materials and Methods

Ethical statement and recruitment

Forty-four children with SDCP, aged between 7 and 15 years, including both boys and girls were recruited for the two groups (pretest and posttest) in a randomized clinical trial by simple random sampling technique. The study was conducted in the department of Physiotherapy, tertiary care teaching hospital and recognized center for special children. Children with SDCP who were able to follow verbal commands and having level II or III of gross motor function classification system were included in the study. Children, who were uncooperative, on antiepileptic and antispastic medications, with hearing deficit, any cardiac anomalies affecting exercise tolerance, and less than 6-month post-orthopedic surgery or post-botulinum toxin injections, were excluded from the study. After obtaining ethical approval from Fortis hospital ethics committee, Mohali, Punjab, India, the study protocol was uploaded in open access clinical trial registry platform, Clinical Trials Registry, India (CTRI) (http://ctri.nic.in/),[19] approved by the World Health Organization’s International Clinical Trials Registry Platform and International Committee of Medical Journal Editors,[20] with unique CTRI registration no. CTRI/2017/12/010791. Written informed consent was obtained from the caregiver/parents of the participants before the study. The detailed study plan is given in Figure 1.

Figure 1

Consolidated Standards of Reporting Trials (CONSORT) flowchart of the study plan

Random allocation

Simple randomization was used to allocate the children with CP into task-oriented activities based on NDT (TOA-NDT) principle group and conventional physiotherapy (CPT) group. Children with SDCP were blinded to their treatment allocation using sequentially numbered, opaque-sealed, envelopes.

TOA-NDT group: This group included the session for trunk activation in frontal, sagittal, and transverse planes in sitting and standing positions performed through hands on facilitation by the therapist. The principles of NDT used in all of these activities are weight shifts and trunk elongation on optimal trunk alignment in sitting and standing positions. In sitting, the activities were reaching and popping of the soap bubble, reaching for a ball in all planes, and transferring the plastic rings from one side to the other side of the table. In standing, along with the aforementioned activities, reaching for the ball to basket in all three planes was included. The child was trained on trunk activities over sagittal plane in sitting (stability) for reaching task in upper limb (mobility) [Figure 2]. The therapist facilitated the child by hands on to meet the requirements of the task by providing optimal alignment of the pelvis for the weight shifts at hips and elongation of the trunk toward reaching side of the task. The child was further challenged for a transverse plane activities in standing while reaching an object [Figure 3]. The therapist facilitated through knee to allow activation at hip joint (stability) for a rotational movement (mobility) in trunk to reach the target object. Each of these activities was performed for 6min with 2–3min rest in between each activity for a total duration of 60min, 6 days/week for 6 weeks.

Figure 2

Reaching activities in sagittal Plane

Figure 3

Reaching activities in transverse plane

CPT group: This group received CPT treatment protocol. The exercises included were passive stretching for the adductors, hamstrings, quadriceps, and calf muscles for both limbs (three repetitions with 10-s hold) active/passive range of motion exercises for bilateral lower limbs in sitting and supine position (three sets with 10 repetitions). Children were asked to remove the pegs from the pegboard placed in front of them and to replace the pegs in the pegboard (10min). They were made to stand on the balance board and perform playful activities such as throwing a ball toward the basket ring placed in front of the children (10min). They were made to stand on the balance board and to perform pegboard activities on the pegboard that was placed on the table in front of the children (10min). Duration of treatment for both groups was 60min/day, 6 days a week for 6 weeks. At the end of 6 weeks of intervention, post-intervention outcome measures were assessed.

Outcome measures

Both the groups were assessed by the following outcome measures. Gross motor function measure-88 (GMFM-88), postural assessment scale (PAS), pediatric balance scale (PBS), and trunk impairment scale (TIS) were the outcome measures used in this study. GMFM-88 was used to measure the gross motor function in children with CP. The inter-rater reliability of GMFM was observed to be excellent [Intraclass Correlation Coefficient (ICC) = 0.95-1].[212223] The PBS, used to determine the dynamic balancing abilities of children with CP, shows an excellent inter-rater reliability.[2425] TIS evaluates static and dynamic sitting balance as well as coordination of trunk movement. TIS has sufficient reliability, internal consistency, and validity for use in clinical practice.[262728] PAS is an instrument of high inter-rater and intra-rater reliability, high test–retest reliability, assess, and monitor postural control.[2930]

Data analysis

The normality of collected data was verified using Levene’s test of normality. As the data followed normal distribution, the descriptive statistics were reported in mean ± standard deviation (SD) and parametric tests confirm statistical significance. Demographic variables were evaluated by Student’s unpaired t-test for continuous measures and chi-square test for dichotomous measures. Statistical tests used to analyze the within-group and between-group comparison were paired sample t-test and independent t-test, respectively. The results were concluded to be statistically significant with P < 0.05 and highly significant with P < 0.01. The effect size index (d) was calculated for each outcome measures using the formula MA – MB/SD, where MA and MB are the means of experiment and control group, respectively, and SD is the pooled standard deviation. The value of d was defined by using the Cohen’s classification of effect size index, where d = 0.2 was considered as small effect size, d = 0.5 was considered as medium effect size, and d = 0.8 was considered as large effect size. All the statistical analyses were performed using the statistical software, the Statistical Package for Social Sciences (SPSS), ver. 16.0 (SPSS, Chicago, Illinois).

Results

Forty-four children with SDCP, of age 9 ± 3 and 8 ± 1 years, were recruited to TOA-NDT group and CPT group, respectively. Baseline demographic and clinical characteristics are shown in Table 1. Most of the study participants were boys with 59% and 41% in TOA-NDT and CPT group, respectively. In both the groups, 52% of subjects had scissoring gait, 11% crouch gait, and 43% used walking aid.

Table 1

Demographic characteristics of the recruited subjects

Characteristic	TOA-NDT group (n = 22)	CPT group (n = 22)
Age (mean [SD])	9.32 (2.94)	8 (1)
Age (in years)
7–9	14	19
10–12	4	2
13–15	4	1
Genders
Male	16	10
Female	6	12
Gait
Crouch gait	2	3
Scissoring gait	10	13
Walking with aid	10	9
vW-sitting	10	7
Spasticity (Ashworth scale)
Grade 1	7	8
Grade 2	10	11
Grade 3	5	4

Within-group comparison of the outcome measures of TOA-NDT group and CPT group is shown in Table 2. As seen in Table 2, a statistically significant improvement was observed in both the groups on all the outcome measures. The within-group change score of 12 (6) of GMFM of TOA-NDT group suggests 14% improvement in the post-intervention period and within-group change score of 4 (2) of GMFM of CPT group suggests 4% improvement in the post-intervention period. The within-group change score of 2 (1) of PAS of TOA-NDT group suggests 12% improvement in the post-intervention period and within-group change score of 0.95 (0.48) of PAS of CPT group suggests 6% improvement in the post-intervention period.

Table 2

Within-group and between-group comparison of all the outcome measures

Outcome variables	TOA-NDT group (N = 22)			CPT group (N = 22)			Between-group comparison
	Pre-outcome mean ± SD	Post-outcome mean ± SD	Post-pre mean ± SD	Pre-outcome mean ± SD	Post-outcome mean ± SD	Post-pre mean ± SD	Post-pre mean (95%CI)	P value
GMFM	68.93 ± 18.20	81.21 ± 16.83	1.23 ± 6.07	67.24 ± 15.31	70.97 ± 14.99	3.74 ± 1.51	8.53 (5.84–11.23)	<0.001
PAS	11.54 ± 2.21	13.40 ± 1.62	1.86 ± 1.04	12.31 ± 1.21	13.27 ± 1.24	0.95 ± 0.49	0.90 (5.84–11.23)	0.001
PBS	29.22 ± 17.59	36.95 ± 17.64	7.73 ± 4.15	24.00 ± 11.80	26.86 ± 12.79	2.86 ± 1.70	4.86 (2.93–6.79)	<0.001
TIS	15.54 ± 4.56	19.31 ± 3.28	3.77 ± 2.20	14.18 ± 2.77	16.50 ± 3.43	2.31 ± 1.49	1.45 (0.30–2.60)	0.014

GMFM = gross motor function measure, PAS = posture assessment scale, PBS = pediatric balance scale, TIS = trunk impairment scale, TOA-NDT = task-oriented activities based on NDT, CPT = conventional physiotherapy

The within-group change score of 8 ± 4 and 3 ± 2 for PBS of TOA-NDT group and CPT group suggests 14% and 5% improvement in the post-intervention period, respectively. The within-group change score of 4 ± 2 for the outcome measure TIS of TOA-NDT group suggests 16% improvement and within-group change score of 2 ± 1 of TIS of CPT group suggests 10% improvement in the post-intervention period.

Between-group comparison of the TOA-NDT group and CPT group outcome measures is shown in Table 2.

As seen in Table 2, statistically significant difference was observed between TOA-NDT group and CPT group in all the outcome measures. The mean difference of the change scores between the groups for GMFM was 8.53 with a large effect size of 1.93. The mean difference of the change scores between the groups for PAS was 0.90 with a large effect size of 1.13. The mean difference of the change scores between the groups for PBS was 4.86 with a large effect size of 1.13. The mean difference of the change scores between the groups for TIS was 4.86 with a moderate effect size of 0.77.

Discussion

The objective of this study was to examine the effects of TOA-NDT principles to improve trunk control, balance, and gross motor function in children with SDCP. The study results showed that TOA-NDT principles were effective in improving the trunk control, balance, and gross motor function in children with SDCP after 6 weeks of intervention. NDT is the most commonly used treatment approach in children with CP.[111213141718] One of the primary objectives of the NDT approach is the facilitation for typical normal postural-controlled movement patterns.[1213] According to the Bobath concept, changes in the nervous system may be organized.[13] Behavioral experiences have the potential to modulate cortical structure and function. Changes in the task, individual, or environment result in the adaptation and reorganization of the nervous and muscular systems.[113132]

Gross motor function has been related to functional outcomes such as activities of daily living.[33] A greater improvement with a large effect size of 1.9 in the gross motor function was observed in the TOA-NDT group compared to that in the CPT group. This indicates improved capabilities in the performance of gross motor skills by the children in TOA-NDT group. Task-oriented activities in different planes through hands on were favorable in facilitating typical movement patterns, thereby improving the trunk control, posture, and gross motor function.[33] Similar findings were reported by Labaf et al.,[18] Fetters and Kluzik,[34] Akbari et al.,[35] and Tsorlakis et al.[15] who reported that the use of NDT in children with CP improved their gross motor function and daily activities. Park[36] investigated the effect of physical therapy frequency based on NDT on gross motor function in children with CP in South Korea for 1 year and concluded that intensive physical therapy was more effective for improving gross motor function such as crawling, kneeling, and standing. Recent studies on the efficacy of a neurodevelopment treatment (NDT)-based sequenced trunk activation protocol to observe the change in gross motor function in infants aged 4–12 months with posture and movement dysfunction concluded that NDT-based protocol was beneficial in improving the gross motor function as compared to that of the conventional therapy.[141516]

Greater improvement in posture, trunk control, and balance was observed in the TOA-NDT group when compared to that in CPT group. Selection of the activities in the NDT group was carried out by considering the components of dynamic stability of trunk through active weight shifts, trunk elongation on an optimal alignment to attain a controlled mobility for reaching an object through facilitation by guiding hands on approach would have contributed to achieve optimal motor recruitment required for the improvement in balance, trunk control, and gross motor function in children of NDT group.

Similarly, Kwon and Ahn[33] reported a greater improvement in GMFM and balance with task-oriented training in children with CP. This proves that truncal stability is an essential core component of balance and coordinated extremity use in daily functional activities and performance of higher level motor tasks. Another study by Rai et al.[37] reported that as motor control proceeds from proximal to distal, the improved level of proximal trunk control leads to improvements in distal lower limb control, which might have helped in attaining better balance.

The study has few limitations such as single-centered study and uncontrolled associated reactions on the nonperformance upper limb, which might have an impact on study outcomes. Further, the study can be performed on the children with other types of CP.

Conclusion

There is sufficient evidence to prove that 6-week study on TOA-NDT principles were effective in improving trunk control, balance, and gross motor function in diplegic CP. Clinical implication of this study is that NDT-based task-oriented activities are superior than CPT in improving trunk control, balance, and gross motor function in children with SDCP.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.