Clinical trial NCT02923167: Robotic-assisted Therapy to Improve Manual Dexterity in Children With Cerebral Palsy
Official title: Robotic-assisted Therapy to Improve Manual Dexterity in Children With Cerebral Palsy: a Pilot Study on Clinical Outcomes and Muscle Synergies as a Possible Predictor of Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: CP
Cerebral Palsy
Robotic
Hand
Rehabilitation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an intervention study including a baseline data collection, 6 weeks of robot-assisted training targeting hand dexterity, and a post-intervention data collection. The study will be conducted in the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, Boston, MA. This study aims to assess the effectiveness of a robot-assisted training on hand dexterity and quality of life in children with cerebral palsy. Additionally, the investigators will study the relationship between muscle synergies and the outcomes of robot-assisted training.

Detailed description: Participants will be assessed 2 times - before and after training with the robot. All the testing and training will be done at Spaulding Rehabilitation Hospital and will include:

Clinical tests:

* A physical examination during which the investigators will measure range of motion and muscular strength at the shoulder, elbow, forearm, wrist, and fingers.
* A test to assess spasticity at the shoulder, elbow, forearm, and wrist.
* A test to evaluate upper extremity function.
* A test to assess unilateral gross manual dexterity.
* A test to assess quality of life (social wellbeing and acceptance, feelings about functioning, participation and physical health, emotional wellbeing and self-esteem, access to service, pain and impact of disability, and family health).

Muscle activity tests:

• A test to get detailed measures of how well participant can perform movements. The measures collected will include the movements of fingers, hands, and arms while picking up different objects. Movements will be tracked by attaching small reflective markers to the fingers, hands, and arms of the participant. Special cameras will be used to collect data. Special sensors (called electromyographic - EMG - sensors) will be attached to the hands and arms to tell the investigators when and how muscles are recruited to generate the movements.

Training with the Robot:

Study participants will undergo robot-assisted training for 18 times - up to 4 times per week during a period of approximately 7 weeks. The training sessions will be carried out by trained study staff. The robot will assist study participants to perform the movements while they attempt to move their fingers to control computer games. The assistance provided by the robot will be adjusted to the ability of each participant to move their hand. Each training session will last about 1 hour. This will include about 20 minutes of stretching exercises, setup time, and warm-up exercises. Study participants will be encouraged to ask for rest breaks whenever needed. The investigators will closely monitor study participants during all study sessions.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cerebral palsy (CP) with upper-limb impairment
* 6 to 18 years of age.
* Manual Ability Classification Scale Level II or III.
* Ability to communicate pain or discomfort.

Exclusion Criteria:

* Use of upper-limb robotics for motor training within the last 3 months.
* Contraindication to robotic-assisted manual training such acute and pronounced pain symptoms despite conventional pain therapy of the upper-limb, lack of compliance, high-grade ataxia, advanced osteoporosis, and fractures of the upper-limb.
* Modified Ashworth Scale (MAS) of 4 in the upper-limb.

Primary outcomes:
measure: Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements
timeFrame: Data collected at baseline and at completion of the 7-week intervention
measure: Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Grasp
timeFrame: Data collected at baseline and at completion of the 7-week intervention
Secondary outcomes:
measure: Change in Box and Block Test Score
timeFrame: Data collected at baseline and at completion of the 7-week intervention
measure: Change in Cerebral Palsy Quality of Life Questionnaire Score - Child
timeFrame: Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up
measure: Change in Number of Muscle Synergies
timeFrame: Data collected at baseline and at completion of the 7-week intervention
measure: Change in Modified Ashworth Scale Score
timeFrame: Data collected at baseline and at completion of the 7-week intervention
measure: Change in Cerebral Palsy Quality of Life Questionnaire Score - Caregiver
timeFrame: Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up
measure: Synergy Similarity
timeFrame: Data collected at baseline and at completion of the 7-week intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spauding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: