Precision Gait Retraining for Children With Cerebral Palsy

• Sponsor: Altec Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04717323
• Collaborator: Columbia University (Other)
• Enrollment: 10
• Locations: 2
• Arms: 2
• Actual Duration (Months): 2.7
• Patients Per Site: 5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This project will develop the first sensor-based mobile Pelvic Assist Device (mPAD) that can deliver precise, adaptable, pelvic control to restore natural coordination of upper- and lower-limb movements during gait in children with Cerebral Palsy

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Gait Disorders, Neurologic	Device: mPAD (or TPAD) Pelvic Assist Device; Device: No Intervention	N/A

Detailed Description

Gait impairments hinder mobility for more than 760,000 children and adults living with cerebral palsy (CP) in the US. Motor relearning is possible for these individual but typically requires numerous training sessions with a team of physical therapists and assistants to restore coupling between upper- and lower-body segments while assisting spastic uncoordinated limb movement to improve gait kinematics. This clinical trial will meet the overall objective of testing the feasibility of developing a smart-robotic exoskeleton that is effective at providing guided pelvic assistance and support while biofeedback mediated training is facilitated under the supervision of a physiotherapist. The project will test a novel tethered Pelvic Assist Device (TPAD) with integratable electromyographic (EMG) and inertial (IMU) biofeedback that is uniquely capable of delivering precise, adaptable, multi-degree-of-freedom pelvic control to promote natural intersegmental coupling, restore coordination of upper- and lower-limb movement, and improve normal gait kinematics in children with CP. Because of its proximity to the center of mass and critical role in coordinating upper- and lower-limb control, the pelvis provides an ideal access point for physiotherapists to manually improve gait. The investigators will test the hypothesis that accurate sensor-based metrics of gait can be derived from EMG and IMU wearable sensors to develop a biofeedback system for motor learning that are integratable with TPAD to develop a new mobile mPAD device that is compliant with the target population.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Precision Gait Retraining for Children With Cerebral Palsy
• Actual Study Start Date: Nov 11, 2020
• Actual Primary Completion Date: Jan 31, 2021
• Actual Study Completion Date: Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients Gait with and without pelvic assistance	Device: mPAD (or TPAD) Pelvic Assist Device; Gait retraining device that applies pelvic forces and measures response; Other Names: mPAD (or TPAD) ; Device: No Intervention; Gait with no pelvic assistance
Experimental: Controls Gait with no pelvic assistance	Device: No Intervention; Gait with no pelvic assistance

Outcome Measures

Primary Outcome Measures

1. Gait Metric Accuracy [1 day]

   Measures the accuracy of identifying heel strike and toe off timing in % error when comparing measures from wearable sensors vs. motion capture

2. Pelvis Range of Motion During Walking [1 day]

   Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture

3. Muscle Activation During Walking [1 day]

   Measures electromyographic (EMG) signals of trunk and lower limb muscles during gait which are necessary for designing and implementing a mobile pelvic assist device (mPAD) system with biofeedback

4. Rating of Perceived Difficulty [1 day]

   Structured interviews will be used to grade the perception of difficulty in using the technology

5. Trunk Range of Motion During Walking [1 day]

   Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture

6. Hip Range of Motion During Walking [1 day]

   Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture

7. Knee Range of Motion During Walking [1 day]

   Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria (children with CP):

• Children (6-18 years of age)

• Male or Female

• Confirmed diagnosis of Cerebral Palsy by a neurologist;

• CT or MRI imaging consistent with clinical presentation;

• Clinical evidence of preserved cognition as determined by the child's neurologist;

• Clinical evidence of Mild to Moderate spastic (pyramidal) diplegia as determined by the child's neurologist;

• Gross Motor Function Classification System (GMFS) GMFCS Level II ("walks with limitations. Limitations include walking long distances and balancing, but not as able as Level I to run or jump; may require use of mobility devices when first learning to walk, usually prior to age 4; and may rely on wheeled mobility equipment when outside of home for traveling long distances."

• Spasticity being controlled by pharmaceutical or surgical correction; or has Modified Ashworth scale (MAS) = 0-2 ("More marked increase in muscle tone through most of the range of motion (ROM), but affected part(s) easily moved

• Ambulatory without assistive devices (except for long distances or on uneven terrain).

• No allergies to skin tape such as Band-Aid.

Exclusion Criteria (children with CP):

• Inability to follow simple instructions in English, or through a Spanish-speaking translator;

• Medical history of other neurological conditions;

• Medical history of cardiac or respiratory complications, or disorders that would place the subject at risk for conducting the different motor activities;

• Contractures present in lower limb - evaluated based on Tardieu Scale test where joint range of motion is measured during slow velocity movements and where contracture is operationally defined as being present if the angle at the end of range is 5 -10 degrees less than full range at ankle; and 5 -20 degrees less than full range at hip and knee.

• Skin disorders that result in open lesions or hyper-sensitive/fragile skin, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;

• Unable to provide Informed Consent from subject and Assent from parent or guardian using English or Spanish-translation informed consent form.

Inclusion Criteria (healthy volunteers):

• Adults or Children (age≥6 y.o.)

• Male or Female;

• Able to walk independently and without assistive devices;

• No history of musculoskeletal or neurological disorders;

• Able to follow directions in English.

Exclusion criteria (healthy volunteers):

• Non-English speaker;

• Unable to walk independently and without assistive devices;

• Medical history of neurological or musculoskeletal conditions (arthritis, spondylosis, etc.);

• Inability to follow simple instructions;

• Unable to provide informed consent in English.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altec Inc.	Natick	Massachusetts	United States	01760
2	CUMC Harkness Pavillion	New York	New York	United States	10032

Sponsors and Collaborators

• Altec Inc.
• Columbia University

Investigators

• Principal Investigator: Paola Contessa, PhD, Altec Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 8, 2021

More Information

Publications

None provided.

• Responsible Party: Altec Inc.
• ClinicalTrials.gov Identifier: NCT04717323
• Other Study ID Numbers: mPAD Phase 1
• First Posted: Jan 22, 2021
• Last Update Posted: Mar 4, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Altec Inc.: CP (Cerebral Palsy); Diplegia, Spastic; Gait Disorders
• Additional relevant MeSH terms: Paralysis; Cerebral Palsy; Nervous System Diseases; Gait Disorders, Neurologic

Study Results

Participant Flow

Arm/Group Title	Patients	Controls
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance
Period Title: Overall Study
STARTED	0	10
COMPLETED	0	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Patients	Controls	Total
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance	Total of all reporting groups
Overall Participants	0	10	10
Age (Count of Participants)
<=18 years	0 NaN	0 0%
Between 18 and 65 years	10 Infinity	10 100%
>=65 years	0 NaN	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.3 (2.8)	27.3 (2.8)
Sex: Female, Male (Count of Participants)
Female	5 Infinity	5 50%
Male	5 Infinity	5 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 NaN	0 0%
Not Hispanic or Latino	10 Infinity	10 100%
Unknown or Not Reported	0 NaN	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 NaN	0 0%
Asian	2 Infinity	2 20%
Native Hawaiian or Other Pacific Islander	0 NaN	0 0%
Black or African American	0 NaN	0 0%
White	8 Infinity	8 80%
More than one race	0 NaN	0 0%
Unknown or Not Reported	0 NaN	0 0%
Region of Enrollment (participants) [Number]
United States	10 Infinity	10 100%

Outcome Measures

1. Primary Outcome

Title	Gait Metric Accuracy
Description	Measures the accuracy of identifying heel strike and toe off timing in % error when comparing measures from wearable sensors vs. motion capture
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Analysis was conducted for control participants that completed the study procedure.

Arm/Group Title	Patients	Controls
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance
Measure Participants	0	10
Mean (Standard Deviation) [percentage of error]	2.01 (1.44)

2. Primary Outcome

Title	Pelvis Range of Motion During Walking
Description	Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Analysis was conducted for control participants that completed the study procedure

Arm/Group Title	Patients	Controls
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance
Measure Participants	0	10
Mean (Standard Deviation) [degrees]	1.40 (0.60)

3. Primary Outcome

Title	Muscle Activation During Walking
Description	Measures electromyographic (EMG) signals of trunk and lower limb muscles during gait which are necessary for designing and implementing a mobile pelvic assist device (mPAD) system with biofeedback
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Analysis was not conducted since patient participants in need of EMG biofeedback were not recruited.

Arm/Group Title	Patients	Controls
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance
Measure Participants	0	0

4. Primary Outcome

Title	Rating of Perceived Difficulty
Description	Structured interviews will be used to grade the perception of difficulty in using the technology
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Analysis was not conducted since patient participants assigned to the pelvic assistance intervention were not recruited.

Arm/Group Title	Patients	Controls
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance
Measure Participants	0	0

5. Primary Outcome

Title	Trunk Range of Motion During Walking
Description	Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Analysis was conducted for control participants that completed the study procedure

Arm/Group Title	Patients	Controls
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance
Measure Participants	0	10
Mean (Standard Deviation) [degrees]	1.34 (0.50)

6. Primary Outcome

Title	Hip Range of Motion During Walking
Description	Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Analysis was conducted for control participants that completed the study procedure

Arm/Group Title	Patients	Controls
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance
Measure Participants	0	10
Mean (Standard Deviation) [degrees]	2.09 (0.90)

7. Primary Outcome

Title	Knee Range of Motion During Walking
Description	Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Analysis was conducted for control participants that completed the study procedure

Arm/Group Title	Patients	Controls
Arm/Group Description	Gait with and without pelvic assistance	Gait with no pelvic assistance
Measure Participants	0	10
Mean (Standard Deviation) [degrees]	3.12 (1.27)

Adverse Events

Time Frame	Through assessment duration, an average of 1 day
Adverse Event Reporting Description	Includes only controls that participated in the study.
Arm/Group Title	Pelvic Assist (Patients)		No Intervention (Controls)
Arm/Group Description	Pelvic assistance applied for gait retraining mPAD (or TPAD) Pelvic Assist Device: Gait retraining device that applies pelvic forces and measures response No Intervention: Gait with no pelvic assistance		Gait with no pelvic assistance No Intervention: Gait with no pelvic assistance
All Cause Mortality
	Pelvic Assist (Patients)		No Intervention (Controls)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/10 (0%)
Serious Adverse Events
	Pelvic Assist (Patients)		No Intervention (Controls)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Pelvic Assist (Patients)		No Intervention (Controls)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/10 (0%)

Limitations/Caveats

Intervention was not assigned due to mandated patient recruitment restrictions resulting from the Covid-19 emergency.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.