Harvey et al. 1997; Australia
Downs & Black = 17
Post-test
N=10

Population: 10 males and females; mean age 37±8.4 yrs; all subjects had a motor complete SCI; T9-T12 lesion level; 4-19 yrs post-injury.
Treatment: Walkabout Orthosis (WO1) vs. Isocentric Reciprocal Gait Orthosis (IRGO): 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 IRGO=0.34 m/s ± 0.18, mean WO=0.14 m/s ± 0.12; p=0.002) 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.

Scivoletto et al. 2000; Italy
Downs & Black = 14
Post-test
N=24

Population: 24 males and females; mean age 33.6±3.2 yrs; AIS A; T1-T12 lesion level; mean 5.3 yrs post-injury (SD 2.1)
Treatment: RGO: training, then home-use for 1 year.
Outcome measures: gait 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.

Franceschini et al. 1997; Italy
Downs & Black = 14
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).

Nakazawa et al. 2004; Japan
Downs & Black = 13
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 (Weight-bearing control orthosis): 1 hr, 5x/wk, 12 wks
Outcome measures:Gait velocity

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

Saitoh et al. 1996; Japan
Downs & Black = 12
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 measures: walking 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
Downs & Black = 12
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

Whittle et al. 1991; UK
Downs & Black = 12
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.

Winchester et al. 1993; USA
Downs & Black = 11
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 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.

Massucci et al. 1998; Italy
Downs & Black = 10
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.

Sykes et al. 1996b;
United Kingdom
Downs & Black = 10
Post-test
N=5

Population: 5 males and females; age 24-37 yrs; all subjects had a diagnosis of AIS A-C; C2-T6 lesion level .
Treatment: Following conditioning program, RGO+FES bilaterally to quadriceps and hamstrings for home use.
Outcome measures: Walking speed over 40 m.

1. When subjects walked with RGO alone, they achieved walking speeds ranging from 0.13 to 0.40 m/s.

Marsolais et al. 2000; USA
Downs & Black = 9
Post-test
N=6

Population: 6 males and females; age 22-50 yrs; all subjects had a SCI; C7-T12 lesion level; 2.5-20.6 yrs post-injury.
Treatment: Case-Western Reserve University Hybrid Gait Orthosis (modification of IRGO) combined with FES to various muscles (combination of 8-16 muscles).
Outcome measures: Walking speed and distance.

1. 2 subjects who used the IRGO alone achieved distances of 3-90 m during overground walking with either standard walker or crutches.

Thoumie et al. 1995; France
Downs & Black = 8
Post-test
N=26

Population: 26 males and females; age 20-53 yrs; all subjects had a complete SCI; C8-T11 lesion level; 9-144 months post-injury.
Treatment: RGO-II orthosis: Long-leg brace with recripocal hip joint combined with FES to the quadriceps and hamstrings. 4-6 wks of gait training with orthosis alone followed by RGO-II + FES (hybrid) program (total program time: 2-5 months inpatients, 3-14 months outpatients).
Outcome measures: Walking distance and speed with RGO and with RGO+FES.

1. When subjects with RGO-II alone, they achieved distances of 150-400m. Average walking speed was 0.29 m/s (SD 0.03; range 0.22-0.41 m/s).