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Trial registered on ANZCTR


Registration number
ACTRN12615000900516
Ethics application status
Approved
Date submitted
10/06/2015
Date registered
27/08/2015
Date last updated
27/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Neuro-rehabilitation on the Quality of Motor Planning in Adolescents with Down’s Syndrome
Scientific title
The effect of neurodevelopmental treatment and sensory integration method and additional treatment methods (dynamical brace - Adeli suit type; kinesiology taping) on visual perception and quality of motor planning among children and adolescents with Down Syndrome and/or intellectual disability.
Secondary ID [1] 286893 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Down Syndrome 295297 0
intellectual disability 295453 0
Condition category
Condition code
Neurological 295560 295560 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 295708 295708 0 0
Down's syndrome
Mental Health 296213 296213 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The three intervention groups received neuro-rehabilitation therapy for 10 months, whilst the control group received standard therapy based on the curriculum of the Polish special education system. The standard therapy comprised physical education and adapted physical activity classes but did not include neuro-rehabilitation or physiotherapy.
Group (G1) received one hour per week of neuro-rehabilitation therapy based on the Bobath Method and the SI Method.
Group 2 (G2) received one hour per week of neuro-rehabilitation therapy based on the Bobath Method and the SI Method and additional, Children with Down’s syndrome played team sports and movement games wearing the dynamic orthosis during the hour after a neuro- rehabilitation session.
Group 3 (G3) received one hour per week neuro-rehabilitation therapy based on the Bobath Method and the SI Method and additional, Children with Down’s syndrome played team sports and movement games wearing the dynamic orthosis during the hour after a neuro-rehabilitation session, and after it, therapy was supplemented and fixed by use of kinesiology tape. Application if kinesiology tape was held 4-6 days.
The control group (G4) received one hour per week of general development and corrective gymnastics, conducted by physiotherapist or teacher of physical education, according to the curriculum in a special school.
Each test group received the intervention of one on one (physiotherapist – person with DS).
The aim of Bobath Method [Neurodevelopmental Treatment (NDT)] was normalisation of postural tension, which affects development of central stabilisation. Modification of alignment of various segments of the body, focused on crucial points (head, shoulder and pelvic girdle) and control points (upper and lower limbs) was used to promote changes in postural and motor habits. Techniques included provision of effective support as well as basic (suppression and priming) and special (pressure, traction, placing, alternative tapping, inhibitory tapping, pressure tapping, sweep tapping, push-pull) techniques. Physio balls, rollers, mattresses and mirrors were used as required.
The intervention also included techniques based on the SI Method. The main objective of this type of neuro-rehabilitation is to provide controlled exposure to sensory stimuli, especially vestibular, proprioceptive and haptic stimuli, to facilitate an adaptive reaction. To promote effective organisation of the CNS at synaptic level and thus ensure that sensory information is processed appropriately children are encouraged to perform complex motor tasks; the tasks are designed to be appealing to children. Therapy based on this technique is thought to improve sensorimotor coordination. Supports are adjusted according to the participant’s developmental level.
Two-piece suit (shorts and jacket with elastic bands tension (Dunag) – Adeli suit. Elastic bands, are minimal tensioned from shoes, through the knees, hips, torso until your shoulders. Increased pressure on the articular surfaces cause proprioceptive stimulation in normal postural and motor patterns. As a result, a muscle activity directed against the acting force of gravity, resulting in normalization of muscular tension. Children suits enable the children to better “feel” their body, allowing them to function better. Children wearing these suits feel the tension on their body and this then also allows them to perform better at physical tasks.
In study kinesiology taping was used try to enhance central stabilisation and lower limb control. To achieve the desired effect kinesiology taping was used in conjunction with techniques targeting use of the rectus abdominis muscle and obliquus externus abdominis muscle, mechanical correction of the position of the genu valgum, correction of the position of the Achilles tendon, functional application of kinesiology taping for the dorsiflexion of the foot, mechanical correction consisting in static stabilisation of flat-foot.
Intervention code [1] 292071 0
Rehabilitation
Intervention code [2] 292195 0
Treatment: Other
Comparator / control treatment
Control group (G4) received one hour per week general development and corrective gymnastics with physiotherapists or teacher of physical education. They were physical education classes carried out in the hall gymnastics, included gymnastics, games and physical play, exercise to music. They were conducted based on current standards of teaching in special schools for children with intellectual disabilities.
Control group
Active

Outcomes
Primary outcome [1] 295278 0
The Marianne Frostig Developmental Test of Visual Perception
Timepoint [1] 295278 0
Baseline and after treatment (10 months)
Primary outcome [2] 295279 0
Test for Creative Thinking- Drawing Production (Urban K.)
Timepoint [2] 295279 0
Baseline and after treatment (10 months)
Primary outcome [3] 295280 0
Kasperczyk test for body posture assessment
Timepoint [3] 295280 0
Baseline and after treatment (10 months)
Secondary outcome [1] 315259 0
The Violet Maas Clinical Observation Sheet, as well as OTR and FOTA (translated by Zbigniew Przyroski) were used in the study. Each task was carefully explained verbally, and also non-verbally when needed. The understanding of the task by the participant was not of interest. The aim was to evaluate the quality of performance of the task, therefore in cases of total lack of comprehension it was permitted to demonstrate the task directly on the participant (non-verbally) and then evaluate the next unassisted trial by the participant. Each participant of the study was allowed to first perform one trial which did not count. Quality of performance was measured.
The following scoring system was used:
Norm – 3 points
Minor abnormalities – 2 points
Major abnormalities – 1 point
The participants were asked to perform 14 basic trials:
1. “Supine flexion” – the participant assumed default position (lying on the back on a mattress), then crossed the upper limbs on the chest and bent the lower limbs in the pelvic and knee joints. The aim was to lift the head and the bent lower limbs in the direction of the chest. The time of static hold of this position was measured and then translated into points.
2. “Prone extension” – the participant was to assume default position – lying on the chest on a mattress with upper limbs lifted in the direction of the head bent in shoulder joints and extended in elbow joints. The aim was to lift the head, upper and lower limbs against the power of gravity and hold this position for as long as possible. Time was measured with the use of a stopwatch and then translated into points.
3. “Asymmetrical Tonic Neck Reflex” – the participant assumed all fours position with the therapist standing behind. The therapist checked the active support of the upper limbs (elbow joints) before the trial. Then, the therapist was to subtly turn the participants head left and right and to evaluate whether the flexion of the elbow joint on the side of the occiput occurs.
4. “Rapid rotational movements of the forearms – diadochokinesis” – the participant assumed a cross-legged seated position. The aim was for the participant to perform as many precise supination and pronation movements as possible in a time period of 10 seconds. The trial was divided into three stages: first, the movement was performed with one upper limb, then with the other and lastly with both upper limbs. Coordination of movement, potential asymmetry between the left and right side (L/R), co-movements, perseveration, fluidity of movement and difference in performances were all measured during this trial.
5. “The fingers-thumb trial”- a sequence of movements in which the thumb was touching each of the fingers subsequently was shown to the participant. The aim was to perform the trial with one upper limb first, then with the other and lastly with both upper limbs at the same time. Coordination of movement, speed and ease of movement, order of movements, level of visual control, asymmetry and fixation were evaluated.
6. “Chasing eye movements” – eye motility. The patient assumed a cross-legged seated position, facing the therapist. The patient was instructed not to move his head and work only with his/her eyes instead. A pencil with an attractive add-on was held at a distance of 20-25 cm away from the child’s eyes. At first, the pencil was moved horizontally on a stretch of 40 cm, then the pencil was moved vertically and diagonally. Rapid finding of the object, tweaking, delays, crossing the center line of the body and dissociation of the eye and the head. The final outcome of this trial was the median score of the subsequent individual elements of the trial.
7. “The ability of performing slow movements” – in this trial the patient was to imitate the movement of the upper limbs performed by the therapist. The initial position consisted in abducting the upper limbs to a 90 degree angle with flexed elbow joints and hands resting on the shoulders. The aim was to slowly extend the upper limbs and then flex the upper limbs back again. Motor planning, postural tension (the falling of the elbows below shoulder line and hyperextension of the elbow joints), asymmetry (L/R), as well as bilateral coordination were evaluated.
8. “Oral praxia, tongue movement in relation to the lips” – the patient was to imitate various tongue movements presented by the therapist. The following movements were presented: up-down, sideways, around. The median score was taken into consideration. Coordination, fluidity of movements, crossing the centerline of the body as well as range of movement were evaluated.

9. “Co-contraction” – during this trial the therapist placed his hand on the patients head (and trunk afterwards) and commanded the patient: “you are like a rock, you cannot be moved”. The therapist applied gentle pushing movements in various directions on subsequent parts of the child’s body. The patient was supposed to hold still. The trial was performed in a cross-legged seated position. This task required specific, detailed instructions for it was important that the patient understood the exercise clearly.
10. “Upper trunk twists” – the patient was instructed to imitate the upper trunk rotational movements. Incomplete movements, tweaks, coordination disorders and crossing the centerline of the body lowered the score.
11. “Side arm spins” – the patient abducted the upper limbs to a 90 degree angle and performed small circular movements. Completeness of movement and difficulties between the co-operation between the left and the right hemisphere were evaluated.
12. “Front spins” – this trial is a continuation of the task described in item 11. The patient moved his upper limbs in successively wider circular motions leading to the crossing of the centerline of the body.
13. “Background postural movements” – postural adaptation to various situations was observed (cross-legged seated position, sitting at the desk, way of movement and assuming initial positions during trials).
14. “Schilder’s extended arms test” -
a) the patient was requested to assume standing position with feet together and extend the arms forward, spread the fingers and close the eyes. Next, the participant was supposed to count to 20 (in case any difficulties occurred the therapist counted loudly for the patient). Choreoathetotic movements of the fingers, the occurrence of hyperextension in the elbow joints, upper limbs asymmetry and trials of stabilization were evaluated.
b) the therapist was turned backwards to the patient and asked the patient to close his/her eyes, lift the upper limbs forward and hold still. At the same time the therapist manipulated gently the head of the patient. The score was lowered in the following situations: lowering of the upper limbs, moving sideways, difficulty with isolating head and trunk movements.
Timepoint [1] 315259 0
Baseline and after treatment (10 months)
Secondary outcome [2] 315260 0
Southern California Test of Sensory Integration (Jean Ayres)
Timepoint [2] 315260 0
Baseline and after treatment (10 months)
Secondary outcome [3] 315261 0
Eurofit Special Test (Jean-Clana de Potter)
Timepoint [3] 315261 0
Baseline and after treatment (10 months)

Eligibility
Key inclusion criteria
Persons diagnosed with Down’s syndrome and moderate intellectual disability. All participants had a certificate of disability issued by the Counselling Centre For Psychological and Pedagogical Problems stating that they had moderate intellectual disability (Wechsler IQ range: 54 35; ICD-10 F71).
Minimum age
12 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons with additional orthopaedic, neurological and genetic problems not associated with trisomy were excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each patient was assigned to a number on a ball. The balls were placed in a bag. The person responsible for the randomization (unaware of which number was assigned to which participant) drew each ball and placed the balls in boxes of four different colors (until there were no balls left in the bag). Thereafter, another person randomly assigned a group number to a color of a box. Three exercise groups and one control group were created.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants and therapists were blind to certain aspects of the study, such as the object of the study, the number of groups involved etc. The researchers responsible for analysis of the data played no part in administration or delivery of the intervention. Evaluations of motor skill were carried out by a certified physiotherapist . The physiotherapist was blind to the group status of participants.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Kruskal-Wallis test, the Wilcoxon test, two-way Analysis of ANOVA.
Sample size calculation was not assess due to the fact that selection process of the participants (with down syndrome) is difficult to perform. The sample size was determined by the number of people with Down’s syndrome attending the Complex of Schools for Children with Intellectual Disability No. 4 in Sosnowiec, Poland, and the possibilities provided by the period of time in which the observation took place. Lasting nearly one year, the observation period required constant contact with the parents/carers of the participants and the provision of the optimal conditions for the following weeks of therapy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2009
Actual
15/06/2009
Date of last participant enrolment
Anticipated
31/08/2009
Actual
31/08/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6967 0
Poland
State/province [1] 6967 0
Silesia

Funding & Sponsors
Funding source category [1] 291447 0
University
Name [1] 291447 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 291447 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education
Address
Mikolowska 72A, 40-065 Katowice, Polska
Poland
Country
Poland
Secondary sponsor category [1] 290122 0
None
Name [1] 290122 0
Address [1] 290122 0
Country [1] 290122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292998 0
Bioethical Committee at The Jerzy Kukuczka Academy of Physical Education
Ethics committee address [1] 292998 0
Ethics committee country [1] 292998 0
Poland
Date submitted for ethics approval [1] 292998 0
Approval date [1] 292998 0
01/06/2009
Ethics approval number [1] 292998 0
4/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58010 0
Dr Iwona Doroniewicz
Address 58010 0
The Jerzy Kukuczka Academy of Physical Education
Mikolowska 72B
Katowice 40-065
Country 58010 0
Poland
Phone 58010 0
+48 32 207 53 18
Fax 58010 0
Email 58010 0
iwona.doroniewicz@gmail.com
Contact person for public queries
Name 58011 0
Pawel Linek
Address 58011 0
dr Pawel Linek
The Jerzy Kukuczka Academy of Physical Education
Mikolowska 72B
Katowice 40-065
Country 58011 0
Poland
Phone 58011 0
+48 32 207 53 18
Fax 58011 0
Email 58011 0
linek.fizjoterapia@vp.pl
Contact person for scientific queries
Name 58012 0
Pawel Linek
Address 58012 0
dr Pawel Linek
The Jerzy Kukuczka Academy of Physical Education
Mikolowska 72B
Katowice 40-065
Country 58012 0
Poland
Phone 58012 0
+48 32 207 53 18
Fax 58012 0
Email 58012 0
linek.fizjoterapia@vp.pl

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