A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03454412

Enrollment

Registered

2018-03-05

Start date

2018-03-19

Completion date

2019-05-01

Last updated

2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy, Rehabilitation, Hand

Brief summary

The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation System on hand function in children with spastic cerebral palsy.

Detailed description

Intensive Neurophysiological Rehabilitation System is a novel multimodal rehabilitation approach that combines different treatment modalities. The treatment course lasts for 2 weeks with daily therapy up to 4 hours. Main treatment programs include biomechanical correction of the spine, extremity joint mobilization, physical and occupational therapy, reflexotherapy, special massage system, rhythmical group exercises, mechanotherapy and computer games therapy and some other. Preliminary observational studies indicate an improvement of gross and fine motor functions in children with Cerebral Palsy after the treatment course. The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation System on hand function in children with spastic cerebral palsy. About 50 patients with spastic forms of cerebral palsy with mild to moderate impairment of hand function (Level I to III according to Manual Abilities Classification System) would be evaluated before and after the two-week treatment course. This study may help to generate the hypothesis of the effects of the Intensive treatment course on hand function abilities and to prepare a future randomized controlled trial.

Interventions

PROCEDUREIntensive Neurophysiological Rehabilitation

Intensive Neurophysiological Rehabilitation System (INRS) is a combination of different treatment modalities that complement and reinforce each other. It includes spinal manipulative therapy, physical therapy, occupational therapy, joints mobilization techniques, special massage therapy, mechanotherapy, computer games therapy and other treatments with daily duration up to 4 hours.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 15 Years

Healthy volunteers

Inclusion criteria

* Spastic cerebral palsy: uni- and bilateral * Age: 6-15 * Level I-III according to Manual Ability Classification System (MACS)

Exclusion criteria

* Ataxic or dyskinetic cerebral palsy * Non-cooperative behavior * Moderate to severe mental deficit * Severe contractures of upper extremity joints * Upper extremities trauma within 6 months prior to the study * Previous hand surgery * Epilepsy with frequent seizures

Design outcomes

Primary

Measure	Time frame	Description
Jebsen Taylor Hand Function Test for Dominant Hand	Baseline and post intervention (after the two-week treatment course)	The Jebsen Hand Function Test for Dominant Hand assesses hand function activities during performance of activities of daily living of the dominant hand. Test quantifies the time it takes for the subject to do the following standardized functional tasks with one hand: turning over cards, picking up small items, simulating feeding, stacking checkers, picking up light cans, and picking up heavy cans.Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.
Jebsen Taylor Hand Function Test for Non-Dominant Hand	Baseline and post intervention (after the two-week treatment course)	The Jebsen Hand Function Test for Non-Dominant Hand assesses hand function activities during performance of activities of daily living of the non-dominant hand. Test quantifies the time it takes for the subject to do the following standardized functional tasks with one hand: turning over cards, picking up small items, simulating feeding, stacking checkers, picking up light cans, and picking up heavy cans.Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.

Secondary

Measure	Time frame	Description
Box and Blocks Test for Non-Dominant Hand	Baseline and post intervention (after the two-week treatment course)	The test is measuring the dexterity of the non-dominant hand. The score is the number of blocks carried by the non-dominant hand from one compartment to the other in one minute.
ABILHAND-Kids Test Score	Baseline and post intervention (after the two-week treatment course)	Ability of the hand (ABILHAND)-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs. The Parent is asked to fill in the questionnaire by estimating their child's performance of 21 manual activities on a 3-level scale (impossible, difficult, easy). Measured score is expressed in logits ranging from - 7 to +7. The logit is a linear unit that expresses the odds of success of the patient on any given item. The higher score indicates better function.
Maximum Grip Force of the Non-Dominant Hand	Baseline and post intervention (after the two-week treatment course)	Grip force of the Non0Dominant Hand is measured by Jamar hand dynamometer in kilograms. All children had three trials and the best result was recorded
Maximum Grip Force of the Dominant Hand	Baseline and post intervention (after the two-week treatment course)	Grip force of the Dominant Hand is measured by Jamar hand dynamometer in kilograms. All children had three trials and the best result was recorded
Box and Blocks Test for Dominant Hand	Baseline and post intervention (after the two-week treatment course)	The test is measuring the dexterity of the dominant hand. The score is the number of blocks carried by the dominant hand from one compartment to the other in one minute.

Countries

Ukraine

Participant flow

Recruitment details

Patients that met inclusion criteria and scheduled for the treatment to the International Clinic of Rehabilitation were invited.

Pre-assignment details

32 of total enrolled 44 participants met inclusion criteria and were included into the study

Participants by arm

Arm	Count
Intensive Neurophysiological Rehabilitation Patients undergoing two-weeks treatment course of Intensive Neurophysiological Rehabilitation	32
Total	32

Withdrawals & dropouts

Period	Reason	FG000
Baseline Assesment	Physician Decision	12

Baseline characteristics

Characteristic	Intensive Neurophysiological Rehabilitation
Age, Continuous	10.2 years STANDARD_DEVIATION 2.9
Diagnosis Cerebral Palsy, spastic diplegia	11 Participants
Diagnosis Cerebral Palsy, spastic quadriplegia	21 Participants
Dominant hand Left hand dominant	14 Participants
Dominant hand Right hand dominant	18 Participants
GMFCS level GMFCS Level I	8 Participants
GMFCS level GMFCS Level II	10 Participants
GMFCS level GMFCS Level III	13 Participants
GMFCS level GMFCS Level IV	1 Participants
Manual Ability Classification System level Level I	7 Participants
Manual Ability Classification System level Level II	15 Participants
Manual Ability Classification System level Level III	10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	32 Participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	18 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 32
other Total, other adverse events	0 / 32
serious Total, serious adverse events	0 / 32

Outcome results

Primary

Jebsen Taylor Hand Function Test for Dominant Hand

The Jebsen Hand Function Test for Dominant Hand assesses hand function activities during performance of activities of daily living of the dominant hand. Test quantifies the time it takes for the subject to do the following standardized functional tasks with one hand: turning over cards, picking up small items, simulating feeding, stacking checkers, picking up light cans, and picking up heavy cans.Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.