Upper Limb Table 19 Freehand System

Author Year
Country
PEDro Score
Research Design
Total Sample Size

Methods

Outcome

Wuolle et al. 1999
USA
Case Series
NInitial=42; NFinal=30

Population: Age=13-53 yr; Gender: males=26, females=8; Level of injury: tetraplegia; Follow-up time=1 yr post survey, including 6 months of home use.
Treatment: Implemented with a hand neuroprosthesis that provides grasp and release.
Outcome Measures: Functional Evaluations: standardized test of grasp and release, measurements of pinch strength and range of motion & satisfaction survey.

 

  1. General Satisfaction:87% were positive agree or strongly agree, 97% would recommend neuroprosthesis to others, 90% were satisfied with neuroprosthesis, 90% stated neuroprosthesis was reliable, 87% would have surgery again, 80% felt the neuroprosthesis met their expectations, & 77% would pay for the neuroprosthesis if they had the money.
  2. Life Impact: 88% responses were positive for life impact; 90% stated neuroprosthesis improved their quality of life; 87% positive impact on their life (90% reported did not make a negative impact); 83% provided a benefit ADL; 87% responses regarding changes in ADL were positive; 93% participants could perform ADL easier; 93% could perform ADL such as painting and shaving; 90% had increased confidence when performing ADL; 83% could perform ADL more normally; 73% could perform ADL faster.
  3. Independence: 81% of responses were positive; 87% reported they were able to function more independently; 83% used less adaptive equipment; 87% required less assistance from others; 67% felt more comfortable out in the community alone.
  4. Occupation: 57% of responses to occupation questions were positive
  5. Appearance: 87% felt their hand appearance was unchanged or improved.
  6. Usage: used prosthesis median of 5.5 days/week – ranged from 15 participants (44%) who donned the neuroprosthesis 7 days per week to 5 participants (15%) who used it less than 1 day/week; 24/34 participants (71%) used it 4 or more days/week; range of usage C4/C5, C5/C5, C6/C6 levels was the same (0 to 7 days/week) C5/C6 group – used it most regularly 4 to 7 days/week with most participants 8/10 reporting daily use.
  7. Activities:most frequently reported activities included eating, drinking, shaving, brushing teeth, brushing hair, writing, operating a computer, playing games.
  8. Quality of Life: 18/34 positive comments; 1/34 responded neutrally; 1/34 responded negatively.
  9. Improvements: Additional stimulus channels, an implanted command source, smaller, lighter external control unit – easier to don, improve
  10. hand and arm function, make device operable if user is confined to bed.

Carroll et al. 2000
Australia
Pre-post
N=6

 

Population: Mean age=29.1 yr; Gender: males=4, females=2; Level of injury: tetraplegia; Time since injury=1.2 -11.3 yr; Chronicity=chronic.
Treatment: The Freehand System – an implanted multichannel neuroprothesis.
Outcome Measures: Pinch forces; Grasp and Release Test (GRT); Activities of daily living (ADL) test.

 

  1. There was significant improvement in lateral pinch and palmar grasp force after rehabilitation with and without the neuroprothesis.
  2. Force differences were not found between presurgery and rehabilitation without neuroprothesis.
  3. With neuroprothesis, subjects could grasp, move and release more items in the 30 second GRT, as compared to without the neuroprothesis.
  4. In 35/48 ADL events, less assistance was used (physically or assistive equipment) with the neuroprosthesis. In 41/48 ADL events, neuroprosthesis use was preferred in all subjects.
  5. After study, 5/6 subjects still used neuroprosthesis daily.

Peckham et al. 2001
USA/UK/Australia
Pre-post
NInitial=51; NFinal=50

ParticipantsAge=16-57 yr; Gender: males=42, females=9; Level of injury: C5-C6; Time since injury=4.6 yr; Follow-up time=3-13.9 yr.
Treatment: Participants were trained to use the neuroprosthesis and to use it for functional activities. Once they were satisfied with their ability to perform daily activities or when they reached a plateau in proficiency then rehab was complete.
Outcome Measures: Pinch strength, active ROM, Grasp-Release Test, Activities of Daily Living (ADL) Abilities Test, ADL Assessment Test, user satisfaction survey.

  1. When the neuroprosthesis was activated all participants increased their pinch force in lateral pinch (p<0.001) and some increased their pinch force in palmar grasp (p<0.001).
  2. 98% of participants moved at least 1 object with the neuroprosthesis (p<0.001) and 37 improved by moving at least 3 more objects (p<0.001).
  3. Disability was reduced in 49 of 50 participants as measured by the ADL abilities or ADL assessment tools.

Taylor et al.
2001
UK
Pre Post
NInitial=9; NFinal=8

Population: Age=31-48 yr; Gender: males=7, females=1; Level of injury: C4-6; Time since injury=43-430 months; Follow-up time=8-53 months.
Treatment: Interviews- reviewing use of Neuro Control Freehand System.
Outcome Measures: Amount of Care & The System.

  1. No statistical results reported
  2. Completion of personal care was provided by outside nursing agencies. (mean 11.5 h a day, range 3-24 hrs); 4 users had additional care from family members (mean 3.4 h a day, range 2-5 hrs); no users claimed that care given by family members had decreased
  3. System-donning external components 5-10 min; most users reported no significant problems fitting the external equipment; 2 users had problems locating the coil; 3 locating the shoulder controller; 1 had persistent problems maintaining the position through the day due to the adhesive tape used becoming detached (4 reported this as an occasional problem); 4 users had problems with skin allergy to the tape or double sided adhesive rings; 2 users reported that the system made transfers more difficult; 3 users never stopped using the system due to system failure; some problems with equipment reliability; no change in paid caregiver time; 6 users felt more confident when using the system; 7 felt their quality of life had improved.

Memberg et al. 2003
USA
Case Series
N=22

Population: Level of injury: C5-C6.
Treatment: Epimysial or intramuscular electrodes were implanted on the triceps. Following surgery standard stimulation exercise regimens were followed.
Outcome Measures: Elbow extension moments at different elbow positions, performance in controllable workspace experiments, comparison to an alternative method of providing elbow extension in these individuals (posterior deltoid to triceps tendon transfer).

  1. Variation in elbow moment across subjects significantly greater than the variance within subjects (ANOVA p< 0.001).
  2. 10/11 elbows tested elbow moment generated by triceps stimulation at different elbow angles, elbow moment weakest with elbow in more extended position (30 degrees flexion) and peaked with elbow at 90 flexion, significant ANOVA p<0.001.
  3. Elbow moment generated by triceps stimulation at 90 and 120 degrees elbow flexion was significantly greater than elbow moment produced by tendon transfer (ANOVA p<0.05), no difference between elbow extension methods at 30 degrees elbow flexion.
  4. Triceps stimulation and posterior deltoid together provided a greater elbow moment than each method separately, difference significant at each elbow position p<0.05, except at 90 degrees.
  5. Quantitative workspace assessment done on 5 arms, more successful with triceps stimulation, significant for each subject, chi square p<.05).
  6. Average acquisition time with triceps stimulation less than without stimulation 4/5 arms (3.2-6.4 seconds) and significant in 3/5 arms (unpaired t-test p<0.01) and not for one p=0.076. 

Hobby et al.
2001
UK
Pre-post
N=9

 

Population: Age=16-55 yr; Level of injury: tetraplegia.
Treatment: The patients, using an external stimulator, built up the muscles strength in the hand and forearm, to ensure the muscles were in good condition at the time of surgery.
Outcome Measures: Grip Strength, ADL.

 

  1. 7/9 use Freehand System daily.
  2. Provided an active grip of some strength which allowed many functional activities.
  3. Increase in self-confidence.
  4. For over 80% of their selected ADL goals, user preferred to be independent with their Freehand system than use previous method or have activity performed by caregiver.

Kilgore et al. 1997
USA
Case Series
N=5

Population: Age=28-57 yr; Level of injury: C5-C6; Severity of injury: complete; Time since injury=2-9 yr; Chronicity=chronic.
Treatment: Implanted neuroprosthesis.
Outcome Measures: Grasp force; Grasp-Release Test; Tests of ADL (functional independence); Usage Survey.

  1. Pinch force ranged from 8 to 25 N, with stimulation and greater than tenodesis grasp alone; all demonstrated functional grasp patterns and were able to manipulate at least 3 more objects with the neuroprosthesis; had increased independence and were able to use the neuroprosthesis at home on a regular basis; the implanted stimulator proved to be safe and reliable.

Mulcahey et al. 1997
USA
Pre-post
N=5

Population: Age=16-18 yr; Level of injury=C6, Time since injury >1yr.
Treatment: Surgery.
Outcome Measures: Grasp Release Test & ADL Test before and after implementation of the implanted FES hand system.

  1. 40 electrodes implanted, 37 continued to work, all implant stimulators have functioned without problems with follow up ranging between 16 and 25 months.
  2. Grasp Release Test-lateral pinch and palmar grasp forces – Wilcoxon test, FES forces were significantly greater than tenodesis forces for both grasps (p=0.043).

Taylor et al.
2002
UK
Case Series
N=9

PopulationMean age=38.4 yr; Gender: males=7, females=1; Level of injury: C4-C6; Time since injury=10.1 yr.
Treatment: None listed. It was an assessment of the Freehand System.
Outcome Measures: Grasp Release Test, Grip Strength, Activities of Daily Living, Sensory ability (static 2 pt discrimination).

 

  1. Grasp release test results: increase in the types of tasks that subjects could perform (pre n=1.4) and post implantation (n=5.1 p=0.011).
  2. One year post implantation the types of tasks performed was 5.5 p=0.027, without the system it was 1.2 (p=0.028).
  3. Number of repetitions increased post implantation from 12.7 to 37.4 (p=0.028) and without the implant post-implantation (20.2, p=0.046).
  4. At one year number of repetitions was increase to 50.5, p=0.046 with the system and without 24.3, p=0.28.

Smith et al.
1994
USA
Case Series
N=5

 

Population: Age=13-19 yr; Gender: males=5; Level of injury: C5-C6; Time since injury=3-72 months.
Treatment: Intramuscular electrodes were implanted in the upper extremity muscles.
Outcome measures: The Breslow Test – a non-parametric linear rank test used to compare survival chances across subgroups 95% confidence limit used to reject the null hypothesis.

  1. No predicted difference between electrodes in intrinsic and extrinsic muscles (p=0.93).
  2. Significant differences were predicted between exit sites (p=0.016) + across muscle groups (p=0.047).
  3. Survival likelihoods poorer for electrodes exiting dorsally.
  4. At 90 days after implant survivals probabilities of the finger + thumb extensors + thumb abductors were no significant than that of thumb adductor + flexor muscle groups.

Bryden et al. 2000
USA
Case Series
N=4

Population: Age=23-48 yr; Level of injury: C5-C6.
Treatment: Participants were implanted with an upper extremity neuroprothesis including a triceps’ electrode to provide stimulated elbow extension. Participants exercised triceps 4-6 hr/session using a programmed electrical stimulation exercise regimen that includes breaks. Participants exercised either nightly or every other night-whatever was best for maintaining an optimal amount of strength.
Outcome Measures: 5 overhead reaching tasks, amount of assistance required to complete the task & survey of home use.

  1. No statistical analysis was complete.
  2. Passive elbow extension was within normal limits.
  3. With stimulated triceps subjects attained full elbow extension; without it full range was not met.

 

Smith et al.
1996
USA
Case Series
N=5

Population: Age=13-19 yr; Gender: males=3, females=2; Level of injury: C5; Time since injury=3-72 months.
Treatment: FNS vs. Tenodesis.
Outcome Measures: CWRU Hand System (Case Western Reserve University), Grasp and Release Test.

  1. FNS vs. Tenodesis
  2. With FNS and tenodesis each case of improved performance in later sessions was significantly better as compared to the initial session. (p<0.05).
  3. The average grasp forces with FNS increased; the range was from 8.9N (SD+5.2) to 22.5N (SD+8.6) and the palmar grasp forces increases from 2.1N (SD+2.9) to 11.1N (SD+6.0).

Mulcahey et al. 2004
USA
Case Series
N=4

 

Population: Age=13-16 yr; Level of injury: tetraplegia; Time since injury=4-16 weeks.
Treatment: The following muscles were implanted with intramuscular electrodes: Extensor digitorum profundus, extensor pollicis longus, flexor pollicis longus, adductor pollicis, and opponens pollicis for each subject.
Outcome Measures: Muscle Strength-Pinch Force & Hand Function, Performance of ADL, Satisfaction with + without the Freehand System (COPM), Upper Extremity Capacity, Quadriplegic Index of Function.

  1. No statistical results are reported.
  2. No perioperative complications reported.
  3. Subjects began Freehand System use between 2=5 days after implantation.
  4. Muscle Strength-no subject gained significant strength in any key muscle on their freehand limb.
  5. Pinch Force-with Freehand System – each subject realized significant improvement in pinch force.
  6. Upper Extremity Capacity-first 11 questions – no difference with or without Freehand-last set of questions Freehand System improved scores.
  7. Quadriplegic Index of Function-all subjects increased their level of independence.
  8. Freehand System Open-ended Questions-all subjects would repeat implantation.

Note: ADL=Activities of Daily Living; FNS=Functional Neurostimulation

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