Hand-Arm Bimanual Intensive Therapy in Virtual Reality Versus Standard Hand-Arm Bimanual Intensive Therapy

NCT05867368 | Active Not Recruiting DMC

• 1 other identifier: 0154-22-EP
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention study is- 1. To determine if a camp that solely uses VR software based on HABIT (HABIT-VR) still improves the motor planning and execution deficits in children with hemiplegic cerebral palsy (HCP) and 2. To determine if HABIT-VR improves bimanual coordination and affected hand function in children with HCP at least as well as a standard HABIT. Children with motor planning and execution deficits will receive 40 hours of either HABIT-VR or standard HABIT (4 hours per day, 5days/week, for two consecutive weeks), during which the investigators will track their performance of the tasks and their movements through 3-D motion tracking of the VR system. Post-camp, again the investigators will assess upper-extremity motor function. Additionally the investigators will assess pre to post camp improvement in hand function and bimanual coordination using Assisting Hand Assessment (AHA), Manual Ability Classification System (MACS), and manual dexterity using Box and Block test and 9 Hole Peg test.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Hand Arm Bimanual Intensive Therapy; Virtual Reality

Outcome Measures

Primary Outcomes (6)

• Assisting Hand Assessment Score

  The Assisting Hand Assessment (AHA)measure and describe how effectively individuals with a hand/arm impairment use their two hands together to perform bimanual tasks. The scale range from 22 points, meaning that the hand is not used at all, to 88 points meaning that the hand is used effectively, like a normal non-dominant hand. The score reflects the child's ability to use the affected hand in bimanual performance. Higher scores are better.

  Approximately 1 week before the camp

• Assisting Hand Assessment Score

  The Assisting Hand Assessment (AHA)measure and describe how effectively individuals with a hand/arm impairment use their two hands together to perform bimanual tasks. The scale range from 22 points, meaning that the hand is not used at all, to 88 points meaning that the hand is used effectively, like a normal non-dominant hand. The score reflects the child's ability to use the affected hand in bimanual performance. Higher scores ar better.

  Approximately 1 week after the camp

• Box and Blocks Score

  The Box and Block Test (BBT) measures unilateral gross manual dexterity. Children move blocks from one box to another in a minute. The minimum score is zero and there is no maximum score, as the blocks get reset if the child runs out. Higher scores are better.

  Approximately 1 week before the camp

• Box and Blocks Score

  The Box and Block Test (BBT) measures unilateral gross manual dexterity. Children move blocks from one box to another in a minute. The minimum score is zero and there is no maximum score, as the blocks get reset if the child runs out. Higher scores are better.

  Approximately 1 week after the camp

• 9-Hole Peg Test Score

  The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. Children pick up pegs and try to place them in holes on a game board. The minimum score is zero and there is no maximum score, as it is a rate per second of how fast the child places the pegs. Lower scores are better.

  Approximately 1 week before the camp

• 9-Hole Peg Test Score

  The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. Children pick up pegs and try to place them in holes on a game board. The minimum score is zero and there is no maximum score, as it is a rate per second of how fast the child places the pegs. Lower scores are better.

  Approximately 1 week after the camp

Secondary Outcomes (9)

• Heart Rate

  Approximately 1 week before the camp for 5 minutes

• Heart Rate

  During the camp up to 40 hours

• Heart Rate

  Approximately 1 week after the camp for 5 minutes

• Galvanic Skin Response

  Approximately 1 week before the camp for 5 minutes

• Galvanic Skin Response

  During the camp up to 40 hours

Study Arms (2)

Standard HABIT

ACTIVE COMPARATOR

Children will receive hand arm bimanual intensive therapy the way it is typically delivered. Children will receive 40 hrs of one-on-one bimanual therapy, delivered as play. Activities will be self-selected, but all options will require both hands to succeed.

Behavioral: Standard HABIT

HABIT-VR

EXPERIMENTAL

Children will receive hand arm bimanual intensive therapy, however, it will be through the use of custom virtual reality games. Children will receive 40 hrs of one-on-one bimanual therapy, delivered through the virtual reality games. Activities will be self-selected, but all games have a task constraint, requiring both hands to succeed.

Behavioral: HABIT-VR

Interventions

HABIT-VR BEHAVIORAL

HABIT-VR is a suite of video games designed on the principals of HABIT treatments. The games are delivered in virtual reality, because these systems provide a way to track the movements of both hands and build software that requires both hands to succeed.

Also known as: Hand arm bimanual intensive training in virtual reality

HABIT-VR

Standard HABIT BEHAVIORAL

HABIT is a camp where children play self-select activities that require both hands to succeed.

Also known as: Hand arm bimanual intensive training

Standard HABIT

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed as HCP.
• Children with HCP having Manual Ability Classification System Score (MACS) between I-IV.
• Parents able to give consent for the assessment and willing to adhere to the assessment and HABIT protocol.

You may not qualify if:

• Children with any other neurological conditions such as diplegic or tetraplegic cerebral palsy CP, birth injuries such as erbs palsy, brachial plexus lesion or peripheral nerve injuries, spina bifida at the upper thoracic level, leading to inability to move the upper extremity.
• Children with known visual impairments such as blindness.
• Children with any obvious musculoskeletal deformity, which will affect the ability to handle objects.
• Children with musculoskeletal problems such as torticollis, which will affect visual gaze and visual tracking of an object.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Munroe-Meyer Institute

Omaha, Nebraska, 68106, United States

Location

Related Publications (1)

• Gehringer JE, Fortin E, Surkar SM, Hao J, Pleiss M, Jensen-Willett S. Hand-Arm Bimanual Intensive Training in Virtual Reality: A Feasibility Study. Pediatr Phys Ther. 2023 Jan 1;35(1):85-91. doi: 10.1097/PEP.0000000000000975. Epub 2022 Dec 2.

  PMID: 36459077 BACKGROUND

Study Officials

• James E Gehringer, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned based on which camp is being offered that summer. The investigators enroll on a first-come, first serve basis, until the camp is full.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 22, 2023
• Study Start: July 18, 2022
• Primary Completion: June 21, 2024
• Study Completion (Estimated): September 21, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: De-identified data will be released after conclusion of data collections (planned for mid 2024), conclusion of data analysis (planned for end of 2024), and submission of publication (planned for end of 2024/early 2025)
• Access Criteria: Data will be made available upon reasonable request.

Locations

US (1)