Table 7: Upper Limb Robotic Interventions

Author Year

Country

Research Design

Score

Total Sample Size

Methods Outcome

Frullo et al., 2017

USA

PCT

N=17

Population: Assist-as-needed (AAN) robotic controller: Mean age=53.5 yr; Gender: not reported; Time since injury: 16 yr; Level of injury: C3 – C6.

Subject-triggered (ST) robotic controller: Mean age=53.5 yr; Gender: not reported; Time since injury: 16 yr; Level of injury: C3 – C6.

Intervention: Participants were assigned to AAN or ST robotic controller groups. One wk after the last baseline visit, subjects started a program of robotic training, in ten 90-min long sessions, spread over a period of three to four wk. Outcome measures were assessed at baseline, one wk, two wk, and two mo after treatment.

Outcome Measures: Action Research Arm Test (ARAT); Modified Ashworth Scale (MAS); Grip Pinch Strength assessment (GPS); GRASSP.

1.     No significant difference was observed in the ARAT, MAS, GPS, or GRASSP scores or between groups (p>0.05).

2.     The AAN robotic controller demonstrated gradual improvement in movement quality over the ST robotic controller.

Capello et al., 2018

USA

Pre-Post

N=9

Population: Mean age=49.8 yr; Gender: males=8, females=1; Time since injury: 26.9 yr; Level of injury: C4-C7, tetraplegia=9; Severity of injury: not reported.

Intervention: Tetraplegic patients were administered a hand function test to assess the functionality of a soft robotic glove. Outcome measures were assessed at baseline without the assistive glove and once while wearing the assistive glove.

Outcome Measures: Hand function during ADL tasks (Toronto Rehabilitation Institute Hand Function Test (TRI-HFT)); Object manipulation; Lift force.

1.     The soft robotic glove significantly improved key hand functions to manipulate ADL objects and the mean score between baseline and assisted condition across all TRI-HFT categories (p<0.05).

2.     Lift force increased significantly when using the assistive soft robotic glove (p<0.05).

Kim et al., 2017

Korea

Pre-Post

N=4

Population: Mean age=33 yr; Gender: males=4; Time since injury: 12 yr; Level of injury: C5 – C6; Severity of injury: AISA A=2, B=2.

Intervention: Participants compared writing performance using a new hand assist device (GRIPIT) to writing performance with a conventional penholder and their own hand without any device. Outcome measures were assessed at baseline and while using each assistive device.

Outcome Measures: Quantitative outcomes: Accuracy of writing; Solidity of writing; Qualitative outcomes: Appearance; Portability; Difficulty of wearing; Difficulty of grasping; Writing sensation; Fatigability; Legibility.

1.     Quantitative results showed that GRIPT users perform significantly better on accuracy and solidity of writing than conventional pen holders or with their own hand (p<0.05).

2.     Qualitative results showed that GRIPIT has advantages for writing sensation, fatigability, and legibility; Participants found it more difficult to wear than a conventional pen holder; No difference was observed in portability and difficulty grasping (p>0.05).

 

Backus et al., 2014

USA

Pre-Post

N=18

Population: Mean age: 40.5±13.0 yr; Gender: males=8, females=2; Level of injury: C2-C3=3, C4-C7=7; Mean ASIA motor score: 15.8±3.9; Mean time since injury: 3.0±1.1 yr.

Intervention: Test effect of assisted movement with enhanced sensation (AMES) using vibration to antagonist muscle to reduce impairments and restore upper limb function in people with incomplete tetraplegia. Two or three sessions over 9-13 wk per participant.

Outcome Measures: Strength and active motion tests on the AMES device, International Standards for the Neurological Classification of SCI (ISNCSCI) motor and sensory examinations, Modified Ashworth Scale (MAS), grasp and release test (GRT), Van Lieshout Test (VLT), Capabilities of Upper Extremity questionnaire (CUE).

1.     No significant change in MAS scores (p=0.371) or ISNCSCI scores (p=0.299 for motor, p=0.459 for sensory-light tough, p=0.343 for sensory-pin prick).

2.     Strength test scores increased significantly for MCP extension (p≤0.01) and flexion (p≤0.05) and for wrist extension (p≤0.001) and flexion (p≤0.01).

3.     Active motion test scores increased significantly for MCP joints (p≤0.001) and wrist (p≤0.001).

4.     Out of GRT, VLT and CUE scores, only GRT scores were significantly improved after training and slightly between post treatment and 3-mo post treatment (p=0.025).

 

Cortes et al., 2013

USA

Pre-Post

N=10

Population: Mean age: 44.8±16.3 yr; Gender: males=8, females=2; Level of injury: C4-C6=10; Severity of injury: AIS-A complete=3, AIS-B incomplete=4, AIS-C incomplete=1, AIS-D incomplete=2; Mean time since injury: 4.7±2.5 yr.

Intervention: Chronic tetraplegic SCI patients participated in a 6-wk wrist-robot training protocol (1hr/day, 3 times/wk) to evaluate feasibility, safety and effectiveness on upper limb.

Outcome Measures: Motor performance, Corticospinal excitability, Upper extremity Motor score (UEMS), Visual Analogue Scale (VAS), Modified Ashworth Scale (MAS), resting motor threshold (RMT), Motor evoked potential (MEP) amplitude and latency at rest, MEP facilitation.

1.     Significant improvements in aim and smoothness (p=0.03).

2.     No changes in deviation, mean speed, peak speed and duration of movement was found.

3.     No changes in motor strength of trained right arm (p=0.4) or untrained left arm (p=0.41).

4.     No significant changes in MAS of either arm (p>0.05 for both).

5.     No significant changes in pain levels after training (p=0.99).

6.     There were no changes in any neurophysiological parameters after the 6-wks of training (p>0.05).

7.     Strong positive correlation between change in smoothness according to the initial spasticity level (R2=0.403); change in aim was positively correlated with initial spasticity in trained arm (R2=0.123)

8.     Initial UEMS and MEP amplitude had no correlation with the change on smoothness and aim.

Tigra et al., 2018

France

Post-Test

N=5

Population: Mean age=36.4 yr; Gender: not reported; Time since injury: 10.7 yr; Level of injury: C5 – C7; Severity of injury: AISA A=4, B=0, C=1, D=0.

Intervention: Participants piloted a newly developed assistive device (human-machine interface) for hand grip function that utilizes EMG signals from selected muscles to operate a robot hand.

Outcome Measures: Voluntary muscle contraction (EMG); Hand grasping.

1.     Although no statistics were reported, all subjects were able to individually contract the tested muscles on demand for at least 7 s (indicated by EMG), except for one participant with no voluntary contraction. EMG signals were turned into functional commands to pilot the hand.

2.     The tasks (holding an object in the robot hand for 5 s, open hand, palmar pinch and key grip) were successfully achieved with each tested muscle, however, no statistics were reported.

Popovic et al., 1999

Yugoslavia

Pre-Post

N=12

Population: Mean age: 26.5 yr; Level of injury: C5-C7; Severity of injury: complete=10, incomplete=12; Length of experience with device: ≥6 mo.

Intervention: Subjects utilized a bionic glove to complete functional testing of quantitative and qualitative outcome measures.

Outcome Measures: Quadriplegia Index of Function (QIF), Functional Independence Measure (FIM), Upper Extremity Function Test, Goniometric Measurements.

1.     QIF: mean was 19.0±6.5 at the beginning; at the end 28.4±5.2, improvement of 49.5%.

2.     FIM: 63.8±10.4 at the beginning; 79.0±8.9 after six mo. When three clients excluded who had 120 points on FIM scores were beginning 44.4±13.5 and 64.8±16.6 after six mo (increase of 20.4 points/46%).

3.     Functional task completion: six subjects continued to use the device. On average, 75% of the functions were performed better after six mo of use. 6/12 (50%) did not continue to use the device. C6-C7 individuals may find the device beneficial enough to use it as an assistive device.

4.     Technical improvements, specifically cosmetics, positioning of the electrodes, donning/doffing, should increase the number of regular users.

5.     Best candidates are individuals with complete C6-C7 tetraplegia.

6.     FIM score between 25-50 (up to 75), QIF between 0-13 (up to 27), are motivated to use it, can demonstrate efficient grasp.

Prochazka et al., 1997

Canada

Pre-Post

N=9

Population: Age: 22-42 yr; Gender: males=8, females=1; Level of injury: C6-C7; Time since injury: 16 mo–22 yr.

Intervention: Use of bionic glove.

Outcome Measures: Mean peak force of tenodesis grasp, Qualitative ratings of manual tasks.

1.     Mean peak force of tenodesis grasp in the nine subjects increased from 2.6 N±3.8 N (passive) to 11.3 N±7.4 N (glove active), significant than peak passive force (p=0.0064, t-test), and significant at end of fifth grasp 6.8 N±4.2 N, p=0.0064, Mann-Whitney rank sum test.

2.     Most manual tasks improved significantly with the use of the glove.

Coignard et al., 2013

France

Observational

N=63

Population: Injury Group (n=29): Mean age=37.8±13.3 yr; Injury etiology: spinal cord=23, post-stroke locked in syndrome=2, arthrogryposis=1, quadruple amputee=1, cerebral palsy=1, spinal muscular atrophy=1; Controls (n=34): Mean age=32.4±11.2 yr.

Intervention: No intervention. To evaluate the reliability and functional acceptability of the ‘‘Synthetic Autonomous Majordomo’’ (SAM) robotic aid system in a domestic environment using three multi-step scenarios: selection of the room in which the object to be retrieved was located, selection of the object to be retrieved, the grasping of the object itself and the robot’s return to the user with the object.

Outcome Measures: Selection time (time between task’s “start” command and room/object selection click), Number of failures, Qualitative questionnaire.

1.     No significant difference between scenarios 1 and 2 in room/object selection, validation times and number of failures for controls and patients (p>0.05).

2.     Statistically significant difference between scenario 2 and 3 in object selection time for controls and patients (p<0.05) but not for number of object selection failures (p>0.05).

3.     Patients took significantly longer to select the room and the object than the controls did (for room selection in scenarios 1 and 3 and for object selection in all three scenarios) (p<0.05).

4.     No significant patient versus control differences in the number of failures (p>0.05).

5.     Experience of computer use had significantly affected speed of task for patients in scenario 3 (p<0.05) and controls in all scenarios (p<0.05).

6.     Overall, the robot was found to be acceptable by both patients and control participants.

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