Finger Movement Training After Stroke

Sponsor
North Carolina State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05621980
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
36
2
37

Study Details

Study Description

Brief Summary

Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. The goal of this study is to evaluate a new intervention that would combine targeted electrical stimulation of selected nerves with use a soft, pneumatically actuated hand exoskeleton to enhance repetitive practice of independent movements of the fingers and thumb in order to improve rehabilitation of hand function after stroke.

The investigators will recruit stroke survivors in the subacute phase of recovery (2-6 months post-stroke). These participants will be involved in a 6-week intervention involving 18 training sessions. During these sessions, participants will train independent movement of the digits of the paretic hand. Evaluation of motor control of the paretic hand will occur prior to initiation of training, at the midpoint of the training period, after completion of training, and one month later.

Condition or Disease Intervention/Treatment Phase
  • Device: Actuated Virtual Keyboard (AVK) system
  • Behavioral: Occupational Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multimodal Intervention to Improve Manual Dexterity in Subacute Stroke Survivors
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: FES + AVK group

This group will use the AVK system in combination with targeted FES to provide training of independent movement of each digit of the paretic hand. This training has two modes: Key Combination and Song. In the Key Combination mode, the subject will attempt to play the discrete key or key combinations specified on the computer screen to practice difficult movements and combinations. In the Song mode, sequential, rhythmic movements will be practiced as the participant is guided to play a series of keys, specified as falling keys, constituting five-note songs. Key Combination will be employed at the beginning and end of each training session to practice discrete movements that proved troubling during the current or previous session. Most of the session will be spent in the Song mode to emphasize the transitions from one movement to the next. In both modes the AVK system will trigger FES for the finger matching the desired key and signal the PneuGlove to resist movement of other digits.

Device: Actuated Virtual Keyboard (AVK) system
The participant controls an avatar hand by the movement of their own digits. Each avatar digit corresponds to a given virtual key. "Sufficient" digit flexion results in "playing" of that key, with visual and auditory feedback of key strike. Participants will wear a soft exoskeleton, the PneuGlove, with embedded bend sensors to provide real-time measurement of digit flexion. Pneumatic resistance to flexion can be applied to each digit independently, along with extension assistance, through air chambers running through the glove. The FES is intended to assist finger flexion by activating extrinsic finger flexor muscles. A high-density 2×8 stimulation electrode grid will be placed over the median and ulnar nerves at the medial side of the upper arm. The stimulator can deliver electrical stimulation to any pair of electrodes. At the beginning of each session, the investigators will identify the electrode pairs which best produce flexion of each digit with minimal discomfort.

Active Comparator: OT Group

An occupational therapist will provide therapy of matching duration to the OT subject group. This will consist of 10 minutes of stretching of the finger muscles, particularly of the extrinsic finger flexors. This stretching will be followed by two 20-minute sessions of therapy focused on active task practice, object manipulation, and individuated movement of the digits. The Canadian Occupational Performance Measure (COPM) will be administered to identify goals that incorporate dexterous use of the paretic hand. Part of each training session will be used to practice these tasks, while the remainder will be used to practice component skills. Active practice will be followed by a final 10 minutes of stretching of muscles of the digits.

Behavioral: Occupational Therapy
Traditional occupational therapy training sessions.

Outcome Measures

Primary Outcome Measures

  1. Change of Jebsen-Taylor Hand Function Test (JTHFT) [Change of value from before the intervention to immediately after the intervention.]

    A standardized and objective measure of fine and gross motor hand function using simulated activities of daily living.

Secondary Outcome Measures

  1. Change of Individuated fingertip force [Change of value from before the intervention to immediately after the intervention.]

    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.

  2. Change of Individuated finger movement [Change of value from before the intervention to immediately after the intervention.]

    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.

  3. Change of Muscle activity [Change of value from before the intervention to immediately after the intervention.]

    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.

  4. Change of Lateral pinch strength [Change of value from before the intervention to immediately after the intervention.]

    Force produced when the thumb pinches against the radial side of the index finger as if holding a key.

  5. Change of 3-point pinch strength [Change of value from before the intervention to immediately after the intervention.]

    Force produced when thumb pinches against the tips of the index and middle fingers.

  6. Change of Touch sensitivity [Change of value from before the intervention to immediately after the intervention.]

    Touch sensitivity will be measured with von Frey hairs (Aesthesio®).

  7. Change of Box and Blocks Test (BBT) [Change of value from before the intervention to immediately after the intervention.]

    A quick, simple and inexpensive test to measures unilateral gross manual dexterity.

  8. Change of 9-Hole Peg Test (9PHT) [Change of value from before the intervention to immediately after the intervention.]

    A standardized, quantitative assessment used to measure finger dexterity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • A single, unilateral stroke 2-6 months prior to enrollment

  • Moderate to mild hand impairment, as determined by a rating of Stage 4-6 on the Stage of Hand section of the Chedoke-McMaster Stroke Assessment

  • Visual capacity to discern specific shapes on the computer screen

  • Capacity to provide informed consent

Exclusion Criteria:
  • Rigid contractures in the joints of the upper limbs, or orthopedic issues precluding joint movement

  • Hemispatial neglect (as assessed by the Behavioral Inattention Test)

  • Excessive pain in the paretic upper limb (visual analog scale of shoulder pain < 70)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • North Carolina State University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Derek Kamper, Associate Professor, North Carolina State University
ClinicalTrials.gov Identifier:
NCT05621980
Other Study ID Numbers:
  • 23989
  • 22-2459
  • 1R21HD105874-01
First Posted:
Nov 18, 2022
Last Update Posted:
Nov 18, 2022
Last Verified:
Nov 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 Derek Kamper, Associate Professor, North Carolina State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2022