Trial Outcomes & Findings for A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation (NCT NCT03454412)

NCT ID: NCT03454412

Last Updated: 2021-05-25

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 44 participants
• Primary outcome timeframe: Baseline and post intervention (after the two-week treatment course)
• Results posted on: 2021-05-25

Participant Flow

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

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

Participant milestones

Measure	Intensive Neurophysiological Rehabilitation Patients undergoing 2 weeks treatment course
Baseline Assesment STARTED	44
Baseline Assesment COMPLETED	32
Baseline Assesment NOT COMPLETED	12
Treatment Course STARTED	32
Treatment Course COMPLETED	32
Treatment Course NOT COMPLETED	0
Final Assesment STARTED	32
Final Assesment COMPLETED	32
Final Assesment NOT COMPLETED	0

Reasons for withdrawal

Measure	Intensive Neurophysiological Rehabilitation Patients undergoing 2 weeks treatment course
Baseline Assesment Physician Decision	12

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intensive Neurophysiological Rehabilitation n=32 Participants Patients undergoing two-weeks treatment course of Intensive Neurophysiological Rehabilitation
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Dominant hand Right hand dominant	18 Participants n=5 Participants
Dominant hand Left hand dominant	14 Participants n=5 Participants
Diagnosis Cerebral Palsy, spastic diplegia	11 Participants n=5 Participants
Diagnosis Cerebral Palsy, spastic quadriplegia	21 Participants n=5 Participants
Age, Continuous	10.2 years STANDARD_DEVIATION 2.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Manual Ability Classification System level Level I	7 Participants n=5 Participants
Manual Ability Classification System level Level II	15 Participants n=5 Participants
Manual Ability Classification System level Level III	10 Participants n=5 Participants
GMFCS level GMFCS Level I	8 Participants n=5 Participants
GMFCS level GMFCS Level II	10 Participants n=5 Participants
GMFCS level GMFCS Level III	13 Participants n=5 Participants
GMFCS level GMFCS Level IV	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Neurophysiological Rehabilitation n=32 Participants Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
Jebsen Taylor Hand Function Test for Dominant Hand Baseline	130.1 seconds Standard Deviation 83
Jebsen Taylor Hand Function Test for Dominant Hand Post intervention	115.2 seconds Standard Deviation 77

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Neurophysiological Rehabilitation n=32 Participants Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
Jebsen Taylor Hand Function Test for Non-Dominant Hand Baseline	191.5 seconds Standard Deviation 109
Jebsen Taylor Hand Function Test for Non-Dominant Hand Post intervention	181.4 seconds Standard Deviation 114

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Neurophysiological Rehabilitation n=32 Participants Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
ABILHAND-Kids Test Score Baseline	1.92 score on a scale Standard Deviation 1.8
ABILHAND-Kids Test Score Post intervention	2.26 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Neurophysiological Rehabilitation n=32 Participants Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
Box and Blocks Test for Dominant Hand Baseline	33.5 blocks carried Standard Deviation 12
Box and Blocks Test for Dominant Hand Post intervention	35.5 blocks carried Standard Deviation 13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Neurophysiological Rehabilitation n=32 Participants Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
Box and Blocks Test for Non-Dominant Hand Baseline	28.0 blocks carried Standard Deviation 11
Box and Blocks Test for Non-Dominant Hand Post intervention	29.8 blocks carried Standard Deviation 11

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intensive Neurophysiological Rehabilitation n=32 Participants Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
Maximum Grip Force of the Dominant Hand Baseline	12.1 kilogram Standard Deviation 5.6
Maximum Grip Force of the Dominant Hand Post intervention	11.8 kilogram Standard Deviation 5.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intensive Neurophysiological Rehabilitation n=32 Participants Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
Maximum Grip Force of the Non-Dominant Hand Baseline	10.8 kilogram Standard Deviation 6.0
Maximum Grip Force of the Non-Dominant Hand Post intervention	10.5 kilogram Standard Deviation 4.9

Adverse Events

Intensive Neurophysiological Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Oleh Kachmar

International Clinic of Rehabilitation

Phone: +380324765200

Email: okachmar@ic.reha.lviv.ua

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place