Trial Outcomes & Findings for Robotic-assisted Therapy to Improve Manual Dexterity in Children With Cerebral Palsy (NCT NCT02923167)

Last Updated: 2021-10-22

Results Overview

Upper extremity function assessment (section on dissociated movements). The QUEST is a tool that evaluates the quality of upper extremity function. Data is reported on a scale from 0 to 100 for each assessment. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Data collected at baseline and at completion of the 7-week intervention

Results posted on

2021-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Robotic-assisted Training of the Hand Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Whereas the primary objective of the study was to assess the effects of robot-assisted training in children with Cerebral Palsy, we requested a protocol exception to evaluate the effects of robot-assisted training in 1 child with stroke.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robotic-assisted Training of the Hand n=6 Participants Robotic-assisted training of the hand: Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Age, Continuous	12.0 years STANDARD_DEVIATION 4.0 • n=6 Participants
Sex: Female, Male Female	3 Participants n=6 Participants
Sex: Female, Male Male	3 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants
Race (NIH/OMB) White	4 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=6 Participants
Region of Enrollment United States	6 Participants n=6 Participants
Diagnosis Diagnosis - Cerebral Palsy	5 Participants n=5 Participants • Whereas the primary objective of the study was to assess the effects of robot-assisted training in children with Cerebral Palsy, we requested a protocol exception to evaluate the effects of robot-assisted training in 1 child with stroke.
Diagnosis Diagnosis - Stroke	1 Participants n=1 Participants • Whereas the primary objective of the study was to assess the effects of robot-assisted training in children with Cerebral Palsy, we requested a protocol exception to evaluate the effects of robot-assisted training in 1 child with stroke.

PRIMARY outcome

Timeframe: Data collected at baseline and at completion of the 7-week intervention

Population: We were unable to collect data from 3 study participants.

Outcome measures

Outcome measures
Measure	Robotic-assisted Training of the Hand n=3 Participants Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements	3.5 units on a scale Standard Deviation 4.4

PRIMARY outcome

Timeframe: Data collected at baseline and at completion of the 7-week intervention

Population: We were unable to collect data from 3 study participants.

Upper extremity function assessment (section on grasp). The QUEST is a tool that evaluates the quality of upper extremity function. Data is reported on a scale from 0 to 100 for each assessment. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-intervention.

Outcome measures

Outcome measures
Measure	Robotic-assisted Training of the Hand n=3 Participants Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Grasp	12.1 units on a scale Standard Deviation 20.2

SECONDARY outcome

Timeframe: Data collected at baseline and at completion of the 7-week intervention

Population: We were unable to collect data from 3 study participants.

Gross manual dexterity assessment. The test is administered by using a wooden box divided in two compartments. At the beginning of the test, 150 wooden blocks are positioned in one of these compartments. Then study participants are instructed to move, one by one, the maximum number of wooden blocks from one compartment to the other one in a time interval of 1 minute. The result of the test is the number of wooden blocks moved in 1 minute. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-intervention.

Outcome measures

Outcome measures
Measure	Robotic-assisted Training of the Hand n=3 Participants Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Change in Box and Block Test Score	1.0 wooden blocks Standard Deviation 2.0

SECONDARY outcome

Timeframe: Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up

Population: We were unable to collect data from 4 study participants.

Questionnaire for evaluation of quality of life as reported by the child. The questionnaire covers different domains (e.g. social wellbeing and acceptance). Data is reported on a scale from 0 to 100. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-intervention. The change from baseline to follow-up is calculated by taking the difference between the value gathered pre-intervention and the value gathered at one month follow-up.

Outcome measures

Outcome measures
Measure	Robotic-assisted Training of the Hand n=2 Participants Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Change in Cerebral Palsy Quality of Life Questionnaire Score - Child Baseline vs post-intervention	1.1 units on a scale Standard Deviation 2.3
Change in Cerebral Palsy Quality of Life Questionnaire Score - Child Baseline vs follow-up assessment	2.4 units on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: Data collected at baseline and at completion of the 7-week intervention

Population: We were able to collect data of sufficient quality to enable the proposed analyses only for one subject. We observed 5 muscle synergies both at baseline and at completion of the 7-week intervention.

Outcome measures

Outcome measures
Measure	Robotic-assisted Training of the Hand n=1 Participants Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Change in Number of Muscle Synergies	0 muscle synergies

SECONDARY outcome

Timeframe: Data collected at baseline and at completion of the 7-week intervention

Population: We were unable to collect data from 5 study participants.

Upper extremity muscle spasticity assessment. This scale is administered by manually moving the subject's body segments and evaluate if an involuntary (reflex) response of muscles interfere with the passive movement. If testing a muscle that primarily flexes a joint, the rehabilitation specialist evaluating the subject places the joint in a maximally flexed position and moves it to a position of maximal extension over one second. If testing a muscle that primarily extends a joint, the rehabilitation specialist evaluating the subject places the joint in a maximally extended position and moves to a position of maximal flexion over one second. Spasticity causes a contraction resisting the movement. The strength of the contraction (i.e. force involuntarily generated by muscles) is evaluated on a scale from 0 to 4. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-intervention.

Outcome measures

Outcome measures
Measure	Robotic-assisted Training of the Hand n=1 Participants Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Change in Modified Ashworth Scale Score	-0.5 units on a scale

SECONDARY outcome

Timeframe: Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up

Population: We were unable to collect data from 3 study participants.

Questionnaire for evaluation of quality of life as reported by the caregiver. The questionnaire covers different domains (e.g. social wellbeing and acceptance). Data is reported on a scale from 0 to 100. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-intervention. The change from baseline to follow-up is calculated by taking the difference between the value gathered pre-intervention and the value gathered at one month follow-up.

Outcome measures

Outcome measures
Measure	Robotic-assisted Training of the Hand n=3 Participants Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Change in Cerebral Palsy Quality of Life Questionnaire Score - Caregiver Baseline vs post-intervention	4.0 units on a scale Standard Deviation 5.1
Change in Cerebral Palsy Quality of Life Questionnaire Score - Caregiver Baseline vs follow-up assessment	4.0 units on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: Data collected at baseline and at completion of the 7-week intervention

Subjects will be asked to reach and grasp objects of different sizes and shapes. Surface electromyographic (EMG) activity will be collected from 16 muscles of the upper-limb. EMG data is then analyzed using a mathematical technique (referred to as non-negative matrix factorization) that allows researchers to quantify patterns of co-activation among muscles. The similarity among muscle synergies is estimated by computing the scalar product between corresponding muscle synergies. Results are reported individually for each muscle synergy. The minimum scalar product is 0 and it means that the synergies (pre- vs post-interventions) are highly dissimilar. The maximum scalar product is 1 and it means that the synergies (pre- vs post-interventions) are identical.

Outcome measures

Outcome measures
Measure	Robotic-assisted Training of the Hand n=1 Participants Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Synergy Similarity Similarity for synergy 4	0.77 units on a scale
Synergy Similarity Similarity for synergy 1	0.87 units on a scale
Synergy Similarity Similarity for synergy 2	0.94 units on a scale
Synergy Similarity Similarity for synergy 3	0.96 units on a scale
Synergy Similarity Similarity for synergy 5	0.83 units on a scale

Adverse Events

Robotic-assisted Training of the Hand

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Robotic-assisted Training of the Hand n=6 participants at risk Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
General disorders Unanticipated adverse event	16.7% 1/6 • Number of events 1 • During each 1-hour session, for a total of 18 sessions over 7 weeks

Additional Information

Paolo Bonato

Spaulding Rehabilitation Hospital

Phone: 617-952-6319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place