Table 10: Studies of Hip-Knee-Ankle-Foot Orthosis in SCI

Author Year; Country
Score
Research Design
Sample Size

Methods

Outcomes

Samadian et al. 2015

Iran

Pre-Post

Level 4

N= 6

Population: 6 individuals- 4 males and 2 females; motor complete SCI ranging from T8 to T12; 2 AIS A and 4 AIS B; mean age= 29y; months post injury= 7 to 35 months

Treatment: Patients were trained for 12 weeks of gait training after construction of the orthosis that comprised of five sessions per week for a 2-h period with the orthosis. The gait training program also included passive stretching of the lower extremities, upper limb strengthening and balance training with the orthosis while standing and walking. Gait evaluation was performed at baseline and after 4, 8 and 12 weeks. Walking speed and heart rate were measured to calculate the resulting physiological cost index (PCI).

Outcome Measures:Walking speed, distance walked, energy consumption, physiological cost index (PCI).

  1. Walking distance increased significantly and also did so during the 8–12-week period.

Arazpour et al. 2013b;

Iran

PEDro=4

RCT

N=5

Population: N=5 subjects with T8-T12 SCI (4M, 1F); had ability to walk with an ARGO for a minimum of 50m independently; completed a 12-wk gait training rehab program.

Treatment: Patients were randomized to either an ARGO with solid or dorsiflexion-assist type AFO. They walked at their self-selected speed along a flat walkway.

Outcome Measures: Walking speed, distance walked, cadence, MFES

  1. Mean MFES score when using the ARGO with solid AFOs (45.8 (9.12)) was significantly higher than when using the dorsiflexion-assisted AFOs (42.8(9.73)).
  2. During static dual-elbow crutch support, there was no significant different between the two types of orthosis in the postural sway in medio-lateral direction, but significant difference between them in the antero-posterior direction. During single crutch support, there was a significant difference in both medio-lateral and antero-posterior directions.
  3. Walking speed (7%) and endurance (5%) significantly increased when using the ARGO with dorsiflexion-assisted AFOs compared with solid AFO.

Bani et al. 2013;

Iran

Pre-post

N=4

Population: N=4 subjects with SCI (3M 1F); 24-29 yrs old; 12-36 months post-injury; 1 AIS A, 3 AIS B.

Treatment: Patients completed at least 6 weeks of orthotic gait training using an ARGO with 2 types of AFO. Patients then walked with the orthoses along a 6-m walkway at least 5 times at self-selected walking speed in 2 test conditions: 1) ARGO with dorsiflexion-assisted AFO, 2) ARGO with solid AFO.

Outcome Measure: Walking speed, endurance, cadence, stride length, kinematic and spatio-temporal parameters of walking

  1. Mean walking speed (solid AFO=0.32(0.02); dorsi AFO=0.35(0.01) m/s), cadence (solid AFO=40(2.38), dorsi AFO=42(3.09) steps/min) and stride (solid AFO=94.5(9.25), dorsi AFO=100(9.48) cm) significantly increased for subjects using the ARGO fitted with dorsiflexion AFO compared to ARGO fitted with solid AFO.
  2. Mean ankle joint ranges of motion were significantly increased when walking with the ARGO with dorsiflexion-assisted AFO (11.63(0.75)o)compared to ARGO with solid AFO (8.05(0.51)o). Knee joint ranges of motion were reduced and hip joint ranges of motion were increased, but not significantly.

 

Nakazawa et al. 2004; Japan

Pre-post
N=3

Population: 3 males; age 22-28 years; all subjects had a diagnosis of AIS A; T8 -T12 lesion level; 8-12 months post-injury.

Treatment: WBCO: 1 hr, 5x/wk, 12 wks

Outcome measures: Gait velocity

  1. All subjects showed an increase in gait velocity: 7.7 to 13.2; 11.8 to 21.2, 22.4 to 25m/min

Scivoletto et al. 2000;

Italy

Post-test
N=24

Population: 24 males and females; mean (SD) age 33.6(3.2) yrs; AIS A; T1-T12 lesion level; mean (SD) 5.3 (2.1) yrs post-injury

Treatment: RGO: training, then home-use for 1 year.

Outcome measuresgait speed, going up and down stairs, use of walker or crutches, Garrett Score (out of 6; 6 = community ambulation with no limitations; 1=hospital ambulation).

  1. No difference between RGO users and RGO nonusers for gait speed, stair climbing, or ambulatory aid. However, RGO users achieved home ambulation with limitations or home ambulation (level 2-3), while nonusers achieved hospital ambulation or home ambulation with limitations (level 1-2). No one reached community ambulation levels.

Massucci et al. 1998;

Italy

Post-test

N=6

Population: 6 males; age 16-31 yrs; all subjects had a diagnosis of Frankel A; T3-T12 lesion level; 12-51 months post-injury.

Treatment: Rehabilitation training with advanced RGO for 6-8 weeks (including muscle strengthening, standing balance, gait training, stair climbing) .

Outcome measures: Walking speed over 5 m.

  1. Subjects achieved walking speeds of between 7.8 and 16 m/min with the orthosis.

Franceschini et al. 1997; Italy

Post-test
N=74

Population: 74 males and females; mean age 27 yrs; all subjects had a diagnosis of Frankel A or B; T1-T12 lesion level; mean 37 yrs post-injury

Treatment: Orthoses: RGO (n=53), Advanced RGO (RGO with links between mechanical hip joints and hip and knee joints) (n=17), and HGO (n=4). Practice to don/doff device and functional mobility. Follow-up at hospital discharge and 6 months later.

Outcome measures: Garrett Score, ability to climb up and down 12 steps.

  1. At discharge, 28 patients could climb stairs (13 with crutches, 15 with a walker).
  2. The ability to climb stairs or Garret score at discharge was associated with continued orthosis use. 31 patients achieved functional gait (Garrett = 2-5) and 9 achieved community ambulation (Garrett=4-5). 19 used orthosis only for exercise (Garrett=1).

Harvey et al. 1997; Australia

Post-test
N=10

Population: 10 subjects; mean (SD) age 37(8.4) yrs; all subjects had a motor complete SCI; T9-T12 lesion level; 4-19 yrs post-injury.

Treatment: WO1 vs. IRGO[1]: training with first orthosis 2-3 hours, 2-3X/week for 6-8 weeks, followed by 3-month home trial period. 2-month wash-out period (no orthosis) followed by other orthosis.

Outcome measures: functional skills (e.g., curbs, stairs, donning/doffing, sit-stand), Functional Independence Measure, gait speed over flat and inclined surfaces.

  1. No differences between orthoses re: donning/doffing (“independent”), stairs and curbs (“stand-by” or “minimal”), or level gait (“independent” or “stand-by”).
  2. Tendency for better performance with IRGO for flat walking, ramp walking, and stairs. Faster gait with IRGO on flat (mean (SD) IRGO=0.34 (0.18) m/s, mean (SD) WO=0.14 (0.12) m/s) and on inclined surfaces. IRGO allowed more independent gait; WO easier to go from sit-stand and stand-sit.
  3. Neither orthosis enabled subjects to be fully independent in the key skills necessary for functional ambulation after 8 weeks of training.

Saitoh et al. 1996;

Japan

Pre-post
N=5

Population: 5 males; age 26-36 yrs; 4 subjects had a diagnosis of Frankel A and 1 subjects had a diagnosis of Frankel C; T5-L1 lesion level; 8.4-70 mos post-injury.

Treatment: MSH-KAFO: Long-leg hip-knee-ankle-foot brace with medially-placed single-axis hip joint. Patients were trained to stand and walk using device daily for 2 wks, followed by an exercise program 1-2x/wk.

Outcome measureswalking speed and distance.

  1. 4 of 5 were able to stand without crutches with MSH-KAFO (1 subject needed parallel bars).
  2. 3/5 could climb stairs with crutches and rail.
  3. After 3-10 months of therapy, gait speed improved from 0.05-0.2 m/s to 0.17-0.63 m/s and walking distance ranged from 300 to 4000 m.

Lotta et al. 1994;

Italy

Post-test

N=28

Population: 24 males and 4 females; age 15-48 yrs; all subjects had a diagnosis of Frankel A or B; T3-T12 lesion level; 8-312 wks post-injury

Treatment: 3.5-6 sessions/week, 3-16 weeks training with advanced reciprocating gait orthosis (hip-knee-ankle orthosis)

Outcome Measures: Garrett Scale for ambulation

  1. All patients able to walk at least 30 m with walker or forearm crutches
  2. 3 subjects attained “community” ambulation levels; 17 attained “home” level; 8 remained as “exercise only” ambulation level
  3. Median gait speed with orthosis was 16.6 cm/s

Winchester et al. 1993; USA

Post-test

N=4

Population: 4 males; age 24-36 yrs; 2 subjects with complete SCI and 2 subjects with motor-incomplete SCI; T5-T10 lesion level; 25-58 months post-injury

Treatment: Gait training with RGO or IRGO: 2 hrs, 2-3x/wk (average total time = 35 ± 7.5 hr).

Outcome measures: Gait velocity, cadence.

  1. Overall, subjects achieved overground velocity of mean (SD) 12.7 (1.9) m/min with RGO and 13.5 (2.1) m/min with IRGO; cadence of 30.3 (6.2) steps/min with RGO and 31.3 (7.9) steps/min with IRGO.

Whittle et al. 1991;

UK

Post-test

N=22

Population: 22 males and females; age 21-44 yrs; all subjects had a SCI diagnosis; T3-T12 lesion level.

Treatment: HGO (aka Parawalker) + crutches vs. RGO + rollator walker: Practice period + 4 month home use before being switched to the second orthosis.

Outcome measures: walking speed, cadence, and stride length.

  1. No significant differences between orthoses for gait speed, cadence, and stride length
  2. Mean walking speed with either orthosis was 0.24 m/s.
  3. RGO enabled faster sit-to-stand and stepping up on curbs.

 


1 Similar model to the MSH-KAFO

2Successor model to the RGO (uses a central pivot bar and tie rod arrangement instead of crossed-cable to couple hip flexion/extension). The IRGO is thought to be less fatiguing for subjects compared to RGO (Winchester et al 1993).

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