Trial Outcomes & Findings for Neural Adaptation After Tendon Transfer and Training in Tetraplegia (NCT NCT02768103)

Results Overview

Pinch force recorded in newtons from force sensor mounted to a custom grip

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

after 10 weeks home exercise program with task-based training

Results posted on

2022-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	SCI Transfer + Training Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength) task-based training: 10-week training program incorporates activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SCI Transfer + Training Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength) task-based training: 10-week training program incorporates activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
Overall Study 1 participant did not fit in the fMRI	1

Baseline Characteristics

Neural Adaptation After Tendon Transfer and Training in Tetraplegia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SCI Transfer + Training n=4 Participants Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength) task-based training: 10-week training program incorporates activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Pinch force	8.7 Newtons STANDARD_DEVIATION 6.5 • n=5 Participants

PRIMARY outcome

Timeframe: after 10 weeks home exercise program with task-based training

Pinch force recorded in newtons from force sensor mounted to a custom grip

Outcome measures

Outcome measures
Measure	SCI Transfer + Training n=4 Participants Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength) task-based training: 10-week training program incorporates activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
Pinch Force Post-training pinch force (N)	10.6 newtons Standard Deviation 8.6
Pinch Force Pre-training pinch force (N)	8.7 newtons Standard Deviation 6.5

PRIMARY outcome

Timeframe: after 10 week home exercise program with task-based training

Population: No valid data were recorded. The fMRI data collection program had errors in the protocol that rendered the data useless.

A block design with 10 seconds of rest alternating with 10 seconds of functional movement for 6 minutes will be followed. Participants have visual cues to instruct them in the timing and sequence of the tasks to be performed. Scan time to include a session of elbow flexion and a session for pinch is about 20 minutes. The main outcome measures for the fMRI data will be brain activation defined by intensity and cluster size in response to performing elbow flexion and pinch. Second level analyses will be mixed models effects derived using FSL FLAME for within subjects (pre to post intervention) as well as cross-sectional (non impaired vs. SCI-ns; SCI-ns vs. SCI+TT) individual models (with outlier deweighting and standard settings).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after 10 week home exercise program with task-based training

EMG signal recorded from fine-wire (intramuscular) electrodes normalized to a maximum voluntary contraction

Outcome measures

Outcome measures
Measure	SCI Transfer + Training n=4 Participants Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength) task-based training: 10-week training program incorporates activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
Fine-wire Electromyography of Transferred Brachioradialis Muscle (to Paralyzed Thumb Flexor) pre-training normalized Br EMG	30 percentage of Max Br Contraction Standard Deviation 10
Fine-wire Electromyography of Transferred Brachioradialis Muscle (to Paralyzed Thumb Flexor) post training normalized Br EMG	34 percentage of Max Br Contraction Standard Deviation 10

Adverse Events

SCI Transfer + Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Johanson

VA Palo Alto Health Care System

Phone: 408-250-1982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place