Cerebral PalsyNCT02923167
Robotic-assisted Therapy to Improve Manual Dexterity in Children With Cerebral Palsy
A study testing Robotic-assisted training of the hand in people with Cerebral Palsy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robotic-assisted training of the hand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2017to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Robotic-assisted training of the hand
- Keywords
- CP, Cerebral Palsy, Robotic, Hand, Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted training of the handDevice
Also called Amadeo® - Tyromotion
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).
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted training of the hand | Experimental | 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). Receives: Device: Robotic-assisted training of the hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements
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.
Measured: Data collected at baseline and at completion of the 7-week intervention
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Grasp
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.
Measured: Data collected at baseline and at completion of the 7-week intervention
Secondary outcomes (6)
Change in Box and Block Test Score
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.
Measured: Data collected at baseline and at completion of the 7-week intervention
Change in Cerebral Palsy Quality of Life Questionnaire Score - Child
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.
Measured: Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up
Change in Number of Muscle Synergies
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 number of muscle synergies necessary to accurately reconstruct the individual EMG channel recordings will be herein considered.
Measured: Data collected at baseline and at completion of the 7-week intervention
Change in Modified Ashworth Scale Score
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.
Measured: Data collected at baseline and at completion of the 7-week intervention
Change in Cerebral Palsy Quality of Life Questionnaire Score - Caregiver
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.
Measured: Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up
Synergy Similarity
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.
Measured: Data collected at baseline and at completion of the 7-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start16 May 2017
- Primary completion12 Aug 2020
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spauding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923167
- Sponsor's protocol ID
- 2016P000926
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2016
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02923167
- Acronym / sponsor ID
- 2016P000926
- Conditions
- Cerebral Palsy
- Keywords
- CP, Cerebral Palsy, Robotic, Hand, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted training of the hand | Experimental | Device: Robotic-assisted training of the handTraining 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). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted training of the handAlso: Amadeo® - TyromotionTraining 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). | Device | Robotic-assisted training of the hand |
Primary outcome
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements
Time frame: Data collected at baseline and at completion of the 7-week intervention
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.
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Grasp
Time frame: Data collected at baseline and at completion of the 7-week intervention
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.
6 secondary outcomes
Change in Box and Block Test Score
Time frame: Data collected at baseline and at completion of the 7-week intervention
Change in Cerebral Palsy Quality of Life Questionnaire Score - Child
Time frame: Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up
Change in Number of Muscle Synergies
Time frame: Data collected at baseline and at completion of the 7-week intervention
Change in Modified Ashworth Scale Score
Time frame: Data collected at baseline and at completion of the 7-week intervention
Change in Cerebral Palsy Quality of Life Questionnaire Score - Caregiver
Time frame: Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up
Synergy Similarity
Time frame: Data collected at baseline and at completion of the 7-week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bonato, PhD principal investigator
Spauding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted training of the hand in people with Cerebral Palsy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements (time frame: Data collected at baseline and at completion of the 7-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.